If you have a knack for maintaining the quality of software engineering processes, Aditi Staffing can help you find jobs in software quality assurance. The industry is growing, and looks promising for those searching for the ideal software quality assurance job. Great software quality assurance careers, have never been this easy to land.

Senior Project Manager

Job Reference: 21-00690 Type: Candidate will temporarily sit remote until COVID restrictions lifted where they will then be required to be on site when it re-opens at either Thousand Oaks, CA or Cambridge, MA.
5+ years of experience within Pharma & Biotech
Bachelors Degree (scientific or engineering)
PMP Certification

Must have:
Must recognize late stage and life cycle management
-Commercial development
-Process categorization
-Tech transfer

Key words on resumes: drug substance, DS, drug product, DP, attribute sciences, AS, drug development, cross functional support, PMP, commercialization, strategy, launch, communication, teams

- 5 years of experience as a project manager - Microsoft project and office (distribution of info/creating dashboards)
- Soft skills to work of cross functional teams

**Must have Biology/Biochemistry/Biomedical/Chemistry background. NO IT or facility project management. Please do not submit unless they have that specific background.**

Participate in cross-functional project team(s) from multiple sites, and external partners, to develop innovative drug and combination drug/device products.

Responsible for developing and maintaining project schedules for life-cycle management projects and providing general project management support to product delivery teams.

Partner with process development technical leads and other cross functional partners to identify key deliverables and ensure cross functional alignment and accountability.

Assist by driving decision making for assigned projects in alignment with companies decision model.

Perform project management at a high level of professionalism for projects that utilize internal and external personnel, contract firms, and partners using structured, systematic methodologies to meet business objectives.

Follow company governance processes, procedures, specifications, guidance documents, quality system, and applicable industry standards.

Generate and manage detailed integrated project plans and schedules.

Negotiate and resolve conflicts among team/functional members to accomplish project and business goals.

Ensure participation in functional and cross-functional management reviews.

Establish and manage collaboration and team web sites (e.g. SharePoint).

Track delivery of and create repositories for all project deliverables.

Facilitate and incorporate lessons learned, best practices, etc. across teams.

Support business process improvements initiatives.

Create project reports, dashboards and communications that include appropriate risk analysis.


Skills: ; expertise in running medium to large scale projects ; excellent understanding of project management processes and procedures ; experience with project management and analyst methodologies and best practices ; strong analytical skills ; business process development best practices, change management ; strong MS Project, MS Word, Visio, MS PowerPoint and MS Excel skills ; understanding of systems for sharing and collaboration ; excellent communication skills to work with cross-program resources ; leadership; communication; strategy ; presentation

Targeting 5+ years of Project Management exp. within Bio-Pharm/CMO/CRO
Not looking for IS/IT PM
Targeting exp. with MS Project, SharePoint and BOX

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Software Engineer

Job Reference: 21-00682 Type: Duration:9-12 month(s)

Description/Comment:Senior Human Factors Engineer/ UX researcher
Location: On-Site in San Diego, CA

The User Experience design (UX) Group of the Sony in San Diego has openings for senior human factor engineering /UX researcher position. We are looking for experienced researchers with passion for user experience and consumer products who can plan, manage, conduct UI/UX research, analyze data, create report, present to stake holder and work to improve/fix the usability issues, in order to improve every UX aspects of Sony products. The UX Group is part of a multi-disciplinary team that designs and researches UI/UX for many of Sony products.
The ideal candidate will have extensive research background with user-centered design of consumer products and usability evaluations at various stages of product development as well as structured academic background. He or she will have experience with effectively negotiating interactions with various stake holders such as designers, engineers, and business development.
Responsibilities:
1. Plan and manage research with stake holders which includes surveys, ethnographic field studies, task based usability test sessions, contextual inquiries, expert reviews
2. Project management
3. Recruit participants
4. Create discussion guide moderate sessions, analyze the data and create report
5. Design survey, analyze and create report
6. Present report and work with stakeholders to solve the probem
Desired Skills:
ability to focus on the customers needs
knowledge of basic user-centered design principles
Knowledge of UI industry standards for interface design and user testing methodologies
Experience with statistical analysis of user research, survey creation
ability to work independently and efficiently on complex projects
ability to deliver high quality work on tight schedules
careful attention to detail
strong verbal and written communication skills
ability to collaborate and work as a team
understanding for multi cultures
some prior work done related to accessibility
ability to adopt dynamic and fast pace culture quickly and flexibility
technology savvy and understanding of consumer electronics

Requirements:

Bachelors Degree (or higher) in Human Factors, Human-Computer Interaction with demonstrated experience in an equivalent field min of 3 years
Skilled experience on powerpoint, word, excel and visio.
Prior experience on Qualtrics or similar survey tool

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Technical Program Manager

Job Reference: 21-00681 Type: Job Description: Summary:
The main function of a Technical Program Manager is to provide successful definition, implementation and delivery of complex programs that require cross-functional collaboration and interdependencies across a group of projects and/or related activities.

Job Responsibilities:
Deliver programs within the constraints of scope, quality, time and budget and under circumstances involving multiple moderate-probability, moderate-impact risk factors.
Program-level strategic planning, interaction with executive level management, complex issue resolution, excellent communications and team building skills.
Manage a group or groups of internal exempt and matrixed employees and contractors that serve on the project(s) to deliver systems and systems enhancements that meet specified requirements.
Oversight of project scope definition and management, requirements gathering and documentation, time estimating, project schedule development and tracking, project budget management, project status reporting, issue and risk management, contingency planning, customer interaction, and communications across multiple organizational levels.

Skills:
Project estimating, project scheduling & tracking, customer interaction and management, implementation planning in large organizations
Proven people management and team building skills
Demonstrated ability to be flexible/ adaptable in exercising judgment in a changing environment and to manage competing priorities
Proven ability to learn business processes quickly and to work well with business partners at different levels within the organization
Strong ability to assess risk and apply management principles to technology applications/products and business functions
Experience delivering technology and business application solutions in a large-scale, multi-platform systems environment
Experience with software development lifecycle

Education/Experience:
Bachelor's degree in a technical field such as computer science, computer engineering or related field required. MBA or other related advanced degree preferred.
PMP or PMI certification
Comments for Suppliers:

Bolappa Venkatesh (Venky)
Assistant Manager - Recruitment
O: 910-427-1393
E:venkateshbm@aditiconsulting.com
www.aditiconsulting.com
LinkedIn | Glassdoor

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Logistics Analyst 2

Job Reference: 21-00549 Type: Description/Comment:Summary: The main function of a logistics planning analyst is to coordinate and expedite the flow of work and materials within or between departments of an establishment according to production schedule. A typical planning analyst is responsible for reviewing and distributing production, work and shipment schedules and compiling reports on inventory levels, cost, etc. Job Responsibilities: Examine documents, materials and products, and monitor work processes in order to assess completeness, accuracy and conformation to standards and specifications. Review documents such as production schedules, work orders, and staffing tables to determine personnel and materials requirements, and material priorities. Record production data, including volume produced, consumption of raw materials, and quality control measures. Requisition and maintain inventories of materials and supplies necessary to meet production demands. Skills: Verbal and written communication skills, attention to detail, problem solving and interpersonal skills. Ability to analyze costs related to manufacturing, labor and materials. Ability to accurately document and record customer/client information. Knowledge of applicable laws and regulations related to shipping and production. Previous experience with computer applications, such as Microsoft Word and Excel. Education/Experience: High school diploma or GED required. 2-4 years related experience required.

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ETL Developer

Job Reference: 21-00533 Type: Duration:0-11 month(s)

Description/Comment:Summary: *** is seeking a ETL Developer to be responsible for managing data availability, integration, transformation, and delivery to the data mart. Develops and implements comprehensive data integration processes, standardizes the presentation of information derived from multiple subledger transaction systems, and develops data sources necessary to support financial reporting needs. Job Responsibilities: *Design, implement, automate and maintain large scale enterprise data ETL processes. *Extracts structured and unstructured data from source systems, transforming it to fit business performance management needs, and loading it into a data mart. *Ensures ETL process is developed in modular fashion in shared folders and reusable objects to enforce consistency timely development. *Reviews ETL production design for performance optimization. *Collaborates with business functional leaders by analyzing and evaluating business requirements; diagnose the design, propose/design alternatives and recommendations. *Plans and coordinates the implementation of new data requirements *Oversees the data load production process and the implementation of new data load files in accordance with the department's change management process *Resolves issues through troubleshooting and quick diagnoses. *Ensures data quality by designing and implementing adequate internal controls and monitoring processes. *Includes controls to identify individual ETL flows that are performance issues. *Ensures controls are maintained when designing new structures by utilizing object naming conventions to encourage consistent development and ease of migration from development to test to production. *Works closely with Information Technology staff through the phases of coding and implementation of external data source files providing clarifications as necessary. Maintains effective ongoing communications with the business and IT community and operational management regarding system plans, projects, budgets, expenditures and policies. *Participates in the research and resolution of enterprise data governance issues. Qualifications: *Bachelor's degree in a technical field such as computer science, computer engineering or related field required *10+ years experience required *Experience in providing technical support, covering database administration and operations to include monitoring maintenance capacity, performance monitoring/planning and incident/problem troubleshooting and resolution *Strong knowledge of SQL. *Expert knowledge of relational databases, flat files and non-relational database structures. *Expert knowledge of Help Desk tools and trouble ticket tracking processes. *Expert knowledge of support agreements and their implied service levels. *Proven ability to write excellent technical documentation.

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Sr Associate

Job Reference: 21-00532 Type: **Onsite Immediately**
** Regular working hours**

Responsibilities:
Transition of analytical methods from our early-stage development teams to the pivotal testing laboratory. This will include interfacing with attribute sciences team leads and early stage development teams, performing method assessment / qualification, method optimization, and formatting chromatography data software methods.
Performing high-sample volume testing by High Performance Liquid Chromatography (HPLC), Ultra High-Performance Liquid Chromatography (UHPLC), Capillary Electrophoresis (CE), and Tecan in support of Drug Substance, Drug Product, and Attribute Sciences process development teams, under prescribed timelines. Full documentation of analyses in electronic lab notebook. Performing tracking and trend analysis of method performance.
Hand-off/transfer of testing to our Rapid Analytics teams.
Evaluation of Client platform methodologies to improve testing efficiencies in the Process Analytics and Rapid Analytics teams.
Performing HPLC/UHPLC and CE method qualification studies to support transfer of methods to pivotal Quality Control teams.
Perform forced degradation studies to support product characterization, understanding of product stability and evaluation of product comparability.
Closely collaborate with partner organizations during commercial process development, process characterization and process validation studies to support marketing applications.

Basic Qualifications

Bachelors degree and 2 years of Scientific experience

Preferred Qualifications
B.S. in Biochemistry
Good general biochemistry laboratory skills
Expertise in chromatography including HPLC, UPLC, and CE
Experience performing mass spectrometry
Background with compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy
Strong desire to learn and interest in science
Demonstrated proficiency in method development and experience with method technology transfer. Background in chromatography data software (Waters Empower, Thermo Chromeleon) and/or automation software (Tecan)
Understanding of phase-appropriate GMP compliance and documentation
Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teams

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Developer: Software

Job Reference: 21-00520 Type: Additional important update on knowledge/competence required:
- Angular (must)
- Bootstrap (strongly recommended)




Software Engineers conduct or participate in multidisciplinary research and collaborate with design, layout and/or hardware engineers in the design, development, and utilization of productivity enhancement layout tools and design rule checkers, electronic data processing systems software. Determines computer user needs, advises hardware designers on machine characteristics that affect software systems such as storage capacity, processing speed, and input/output requirements, designs and develops compilers and assemblers, utility programs, and operating systems. Responds to customer/client requests or events as they occur. Develops solutions to problems utilizing formal education, judgement and formal software process.

Qualifications
You must possess the below minimum qualifications to be initially considered for this position. Preferred qualifications are in addition to the minimum requirements and are considered a plus factor in identifying top candidates.
**This will be a remote role, until COVID guidelines are lifted.

Minimum Qualifications:
The candidate must possess a Bachelor's degree (with a minimum of 4 years of experience) or a Master's degree (with a minimum of 3 years of experience) or a PhD (with a minimum of 1 year of experience) in Computer Science, Computer Engineering, Electrical engineering or other related field of study, with experience as stated previously in one or more of the following areas (having more than one will be preferred):
o Linux, C, C++, C# Languages, Script Programming using Perl/Python, Tensorflow
o Software Quality and Testing Practices, AGILE
o Database Concepts, SQL and hardware platform architecture
o Graphics Processing, IC Pattern Formats, CAD Tools for Verification, Fracture, OPC Software Engineering, EDA tool

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Strategic Sourcing Manager

Job Reference: 21-00513 Type: *Ideal candidate will Ideally site on site at RI once it reopens
*Hiring manager is open to remote workers that support EST
*Open to any industry, ideally pharma or biotech
*Must have experience putting contracts together & negotiating
*Candidate will be working in Ariba 30% - must be proficient


*** is searching for a Capital Projects Sourcing Manager, who will have an opportunity to work closely with many different business functions and construction and equipment spend categories in one of the leading Biotech companies in the world. They will understand how large multi-national companies work and how to work within a matrixed corporate environment.

At ***, our mission is simple: to serve patients. After virtual onboarding and training, the Capital Projects Sourcing Manager will be located at our manufacturing facility in West Greenwich, Rhode Island or working remotely may also be a consideration.
Purpose:
Capital Project Sourcing Manager will be assigned to a portfolio of large capital projects valued of *** million+ each and potentially a number of medium capital projects in a *** to *** million range.
Capital Projects Sourcing Manager will provide support to a variety of spend sub-categories including Architectural and Engineering services, Construction Management services, Automation Integration services, Commissioning, Quality and Validation services, and General Construction Contractor and individual Construction Trade Services.
To help execute and implement the sourcing and purchasing needs of ***s US based spend across the Operations organization, Sourcing Manager will also assist in the sourcing of Capital Equipment and construction materials.
To execute sourcing (eRFX) for the Capital Construction and Capital Equipment Global Category Management (GCM) Teams
To be a Procurement Process and Systems expert ensuring compliance with all relevant global sourcing policies and procedures
To be a Contracting lead, leading contracting activities including negotiations and contract creation in Ariba CW, managing ongoing contract management needs and to be accountable for hand-off to Contract-to-Pay teams
JOB SUMMARY
Executing Project-Specific Sourcing Strategies
Work is guided by operational and project related objectives defined by GCM:
o Implement project sourcing strategies across US markets
o Document (in Ariba and Scout) and guide sourcing execution through to implementation
o Manage electronic Request for Proposal and Quotation processes (eRFX)
o Ensure sourcing tactics drive value in specific functional business environments, including legal & regulatory context
o Implement supplier improvement programs through active supplier relationships
o Implements new procedures and processes to drive desired results
o Work closely with the Capital Project Teams to ensure timely execution of eRFX, bid analysis and contractor selection, final approval and execution of contract and/or scope of work for purchase orders in a fast-paced environment

Delivering Value for Customers
Understands business goals and customer needs to implement opportunities while providing training and guidance
Partners with colleagues in Finance and all other Function Heads as appropriate
Supports / Manages delivery and validation of savings for Global Category Managers
Anticipates and prevents potential problems through root cause analysis

Managing Capital Projects and Contracts
Ensure ***s procurement policies are followed and that compliance metrics are met or exceeded, supported through supplier contracts published in Ariba
Inform stakeholders on ***s sourcing policies and procedures, providing support and corrective actions where required
Assists Overall Project Manager with all matters related to strategic sourcing and procurement
Manage commercial relationships as liaison between Project Teams and suppliers
Develop and maintain Project Sourcing Plan with Project Manager as a "living document" throughout project life cycle
Lead selection of Contract Strategy and commercial price structure and incentives/penalties
Lead supplier selection process, whether competitively bid or single sourced
Draft and ensure timely reviews and execution of all Contract documents using Ariba CW
Support ongoing contract management (incl. renewing and renegotiating existing and expiring contracts)
Provide basic training of Contract provisions to Project Team and serve as the source for Contract interpretation and application during project execution
Work with Project Manager and Project Controls Manager to resolve valid contractor disputes, claims and/or change orders
The Capital Projects Sourcing Manager will also receive excellent training, support and knowledge of procurement practices at ***




Qualifications:
8+ years strategic sourcing and capital procurement, operations/manufacturing or project management experience, with hands-on experience working on large multi-year projects of over *** million each.
Has solid understanding of sourcing processes (tendering, supplier negotiations and contracting) in a variety of capital construction categories and use of e-sourcing tools such as Ariba.
Competent in project delivery and independently develops practical solutions (planning, prioritizing and delivery), with experience in working with complex project teams across geographic and functional reporting lines
Excellent communication skills (presentation, virtual team development, etc.) resulting in relationship building and development
Problem solving skills and ability to learn new processes and tools quickly
Able to work with minimal direction, ensuring quality of tasks / service provided by self
Experience using e-procurement tools such as SAP, Ariba and Scout
Applies analytical skills to evaluate and interpret complex situations using different information sources in order to draw and present analytic insights
Highly proficient with MS Office Suite, including Excel
Willingness to Travel (up to 20%)
Fluent business English, written and oral

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QC Data Reviewer

Job Reference: 21-00512 Type: Duration:0-6 month(s)

Description/Comment:Pay Rate: ***/hr
Markup: 50%
Bill Rate: ***

Shift: 2 positions 2nd shift; M-F; 4pm 12am

Phone Screen Template Required- please use the QC Data Reviewer template in the help section of IQN.


"QC Analytical Data Reviewer
*** Cell & Gene Therapy is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. *** Cell & Gene Therapy provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing Client technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a *** Cell & Gene Therapy employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
Key Responsibilities include but are not limited to:
Perform detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC, Capillary Electrophoresis, Bioburden, endotoxin, TOC, and membrane filtration testing, generated by QC Department for compliance with cGMP, internal SOP's, and Specifications, to support production, stability studies, and lab operation.
Review Release and Stability data, trend charts of reference standards, lab equipment calibration records, logbooks, and other review function as needed.
Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy.
Compile data results in accordance to SOP's and QC best practices.
Maintain and update relevant SOP's for data review and reporting as needed and work with analysts to complete any corrections to data notebooks.
Ensure that suitable written records and work undertaken re kept in accordance with cGMP and company procedures.
Receive and organize Batch Records and completed Test Records and pair completed Test Records with associated Batch Records.
Communicate and respond inquiries from internal departments regarding status of results.
Experience & Education:
Associates degree required; Bachelors degree preferred with 2 or more years of experience reviewing Quality Control data for cGMP compliance.
Prior experience in reviewing microbiological assays and environmental monitoring data in a cGMP Quality Control lab required
Prior experience in performing microbiological assays and environmental monitoring in a cGMP Quality Control lab is a plus.
Strong attention to detail and strong organizational skills

*** Cell & Gene Therapy is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics
"

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Quality Control Compliance Specialist

Job Reference: 21-00511 Type: Duration:0-6 month(s)

Description/Comment:Pay Rate: ***/hr
Markup: 50%
Bill Rate: ***/hr

Shift: - 1st shift 8-5pm

Phone Screen Template Required- Please use the QC Compliance Specialist- Juner Torres phone screen template in the "help" section of IQN.


"GENERAL DESCRIPTION/FUNCTION:

This role is responsible for supporting the Quality Control team, including EM Microbiology authoring protocols and SOP, conduct training, change control and critical facilities/utility qualifications, create and review environmental monitoring sampling plans, review alert and action limits, support programs such Environmental Monitoring and compendial testing procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.

DUTIES & RESPONSIBLITIES:

Supports the Environmental Monitoring program:
o Author and Review Environmental Monitoring protocols and SOPs.
o Revise SOPs that have Action and Alert limits to align with new settings
o Review Sampling plans for validation and routine
o Review Alert and Action levels for BWI Harmans suites based on first year data
o Create sample matrix with sample requirements for EMPQ of additional clean room suites at new BWI Harmans facility
Complete maps to identify sample locations for all EM sample types for additional clean room suites at BWI Harmans facility
Attend project meetings; fostering teamwork and project collaboration; communicating effectively with focus on problem-solving; other Quality- related tasks as needed.
Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.
Conducts training on applicable SOPs
Participate in site quality and process improvement initiatives. Represent QC Microbiology on site project teams.
Other duties as assigned

SKILLS & TECHNICAL EXPERTISE:

Experience with Good Manufacturing Practices (GMPs)
Experience with ICH Guidelines / EU GMPs
Ability to quickly learn and navigate electronic systems
Able to work in a team setting and independently under minimum supervision
Ability to work in fast paced environment
Creative individual with excellent trouble shooting skills
Requires the ability to produce results in with limited timelines, Experience with the development / review / approval of CAPAs / Deviations / Investigations within the pharmaceutical/ biologics industry


SUPERVISION:

Work independently under general supervision to meet department / company goals

MEASUREMENT OF PERFORMANCE:

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to the team
Timeliness and accuracy in completion of tasks
Contributions to the team beyond general responsibilities
Identification of areas for improvement and leads implementation strategies for improvement
Exercises good judgment
Demonstrated understanding and adherence to Paragon policies and procedures
Ability to succeed in a team-oriented environment under dynamic conditions

EDUCATION/PREVIOUS EXPERIENCE:

Minimum of a B.S. in a Life Sciences discipline
+8 years experience within the biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory
1-2 years experience in Quality Control / Compliance function
Experience with Environmental Monitoring Programs and microbial testing
Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems
Exposure to Lean Operational Excellence highly desirable
Experience working in electronic systems such as LIMS, EDMS, ERP desirable"

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QC Sample Aliquoting Coordinator

Job Reference: 21-00510 Type: Duration:0-6 month(s)

Description/Comment:Pay Rate: ***/hr
Markup: 50%
Bill Rate: ***/hr

Phone Screen Template Required- please use the QC Aliquoting Coordinator template.

Shift: 1 position 8am-4pm

QC Sample Aliquoting Coordinator BWI
DUTIES & RESPONSIBILITIES:
Respond to other department inquiries regarding status of aliquoting requests
Preparation of labels and label vials for samples
Reconstitution and aliquoting of samples
Sample coordination and receipt from other departments for internal and external testing
Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures
Receive Batch Records and Test Request forms from other departments
Order and receive supplies for groups as necessary
Execute document revisions
Works closely with Manufacturing for scheduling of samples submission to the QC lab. May also interact with Project Managers on sample coordination.
Ensure adequate stock of aliquoting supplies through forecasting of upcoming sample submission
Assist in preparing of samples for shipment to contract laboratories
Assist with tracking sample receipt and chain of custody for internal and contract laboratory submission
Work under general supervision to meet project goals
Flexibility in following unique campaign requirements that may include off-hour and weekend work
Assist with tracking internal / external testing as necessary
Assist with QC reagent preparation as necessary
Perform laboratory cleaning as part of routine work
Assist with maintaining inventory of QC non-critical and critical reagents as necessary
Perform QC document archival activities (i.e. submission and requests to Document Control department)
Other duties as assigned
SKILLS & TECHNICAL EXPERTISE:
Strong pipetting and aseptic technique
Ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision
Able to work in a team setting and independently under minimum supervision
Experience with MS Excel and Word for tracking of testing
Strong organizational skills and attention to detail
Ability to set goals and objectives
Strong ability to understand and implement priorities and workload and to establish strong collaborative relationships with peers

MEASUREMENT OF PERFORMANCE:

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
Dependable and can work with minimal supervision on scheduled tasks
Timeliness and accuracy in completion of projects and paperwork (quantity of work)
Contributions to projects beyond general responsibilities (quality of work)
Identification of problem areas affecting operations (knowledge/problem solving)
Exercises good judgment in dealing with operational problems
Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions

EDUCATION & PREVIOUS EXPERIENCE:

B.S. or A.S. in a Life Sciences discipline preferred and a minimum of 2 years of relevant experience working in a cGMP environment
Experience working in cGMP Quality Control
Strong attention to detail and strong organizational skills
Familiarity with Good Manufacturing Practices (cGMPs)
Strong written and verbal communication skills
Experience working in a Phase III / Commercial Manufacturing setting preferred
Have the knowledge and ability to apply basic scientific and regulatory principles to solve operational and other routine quality tasks

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QC Data Reviewer

Job Reference: 21-00509 Type: Duration:0-6 month(s)

Description/Comment:Pay Rate: ***/hr
Bill Rate: ***/hr
Markup: 50%

- 1st shift 8-5pm

Duration: 6 months

Phone Screen template required, please use the QC Data Reviewer Template in the IQN help section.

"QC Analytical Data Reviewer
*** Cell & Gene Therapy is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. *** Cell & Gene Therapy provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing Client technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a *** Cell & Gene Therapy employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
Key Responsibilities include but are not limited to:
Perform detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC, Capillary Electrophoresis, Bioburden, endotoxin, TOC, and membrane filtration testing, generated by QC Department for compliance with cGMP, internal SOP's, and Specifications, to support production, stability studies, and lab operation.
Review Release and Stability data, trend charts of reference standards, lab equipment calibration records, logbooks, and other review function as needed.
Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy.
Compile data results in accordance to SOP's and QC best practices.
Maintain and update relevant SOP's for data review and reporting as needed and work with analysts to complete any corrections to data notebooks.
Ensure that suitable written records and work undertaken re kept in accordance with cGMP and company procedures.
Receive and organize Batch Records and completed Test Records and pair completed Test Records with associated Batch Records.
Communicate and respond inquiries from internal departments regarding status of results.
Experience & Education:
Associates degree required; Bachelors degree preferred with 2 or more years of experience reviewing Quality Control data for cGMP compliance.
Prior experience in reviewing microbiological assays and environmental monitoring data in a cGMP Quality Control lab required
Prior experience in performing microbiological assays and environmental monitoring in a cGMP Quality Control lab is a plus.
Strong attention to detail and strong organizational skills

*** Cell & Gene Therapy is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics
"

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FAQs

What is Software Quality Assurance?

Software quality assurance (SQA) consists of a means of monitoring the software engineering processes and methods used to ensure quality. The methods by which this is accomplished are many and varied, and may include ensuring conformance to one or more standards, such as ISO 9000 or a model such as CMMI. Engineers applying for software quality assurance jobs are usually hired by software development companies.

What does a Software Quality Assurance Engineer do?

An Engineer who undertakes the responsibility of ensuring that a standard process is undertaken in the software engineering process to develop the best product/service, can be defined as a Software Quality Assurance Engineer. Typically, the role is to write software test cases, which can be automatically implemented, so that bugs and glitches can be identified in the system. This procedure ensures that the product is tested thoroughly before being introduced to the market.

A Software Quality Assurance engineer should understand how a user will behave and anticipate the actions that a user will perform on the software that is being developed. This strengthens the capabilities of the software and equips the consumer with a quality product/service.

What are the technical skillsets & qualifications you require to work in this vertical?

Successful software quality assurance engineers have a broad understanding of computer systems and software standards, are detail-oriented and adept at anticipating user behavior and solving problems efficiently and creatively, says the Princeton Review. Good interpersonal and communication skills are also helpful, since quality assurance engineers work closely with product managers and programmers to address software issues and fine tune products.

What are the certifications required to become a Software Quality Assurance Engineer?

A Bachelor’s degree in Computer Science or equivalent is essential in order to become a Software Quality Assurance Engineer. Quite often companies often look for candidates who have a Master’s in Computer Science and/or in Business Management.

A certification in Quality Assurance will definitely add value to a person’s resume. The American Society for Quality (ASQ), offers a course that will help potential QA Engineers obtain the relevant certification.

What are the career opportunities for a Software Quality Assurance Engineer?

A QA Engineer’s prospects to further his career are purely based on the expertise gained and the line of interest. If Hardware is the stream that interests you, than one can become a Computer Hardware Engineer. If expertise has been gained in programming or software development, than a QA Engineer can move on to become a Computer Programmer.

What does a Computer Hardware Engineer do?
The testing of computer parts, such as the circuit board, routers, networks, processors and other hardware parts of a computer is what a Computer Hardware Engineer will typically do. The usability of the various parts is tested from all aspects to ensure high quality in the assembled product.

Even though the growth has not been exponentially high as compared to similar careers, it is however a stable and steady career to pursue. According to BLS, a Hardware Engineer earns an average salary of approximately $100000 annually.

What does a Computer Programmer do?
Developing code to create software programs is what a Computer Programmer does. The programmer will understand how the user functions and how the software program should respond. This is a fast growing career and the demand has only risen in the past few years. The average salary that a Computer Programmer receives is around $75000 annually (according to BLS).

What is the scope for Software Quality Assurance?

There is high growth in pursuing a career in Quality Assurance. The US market has seen a high demand for these roles, and it is predicted that this demand will only grow. Career span typically begins from a Quality Assurance Engineer to a QA Manager and finally to a QA Lead. There are opportunities for QA engineers to opt for related fields such as analytics etc. The average salary of a QA Engineer is around $58000, as per Salary.com.

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