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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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Scientist

Job Reference: 21-00684 Type: Duration:0-6 month(s)

Description/Comment:Scientist - AR&D
Pay Rate: *** p/hr
Bill Rate: *** p/hr
Mark-up: 45%
Duration: 6 months or longer


This position contributes significantly to the successful timely development of new pharmaceutical products utilizing drug delivery systems and technologies by carrying out required analytical support activities.

Strong background in pharmaceutical separation science (LC, GC, CE)

Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
Preparation of reagents/standards/medias needed for analysis according to established methods.
Safe handling of potent and teratogenic compounds.
Disposal of hazardous waste according to environmental regulations and company/departmental procedures.
Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks.
Capable of self-scheduling of work assignments
Assures right-first-time execution of departmental methods and SOPs.
Facilitates and supports activities and services necessary to the routine operations of the department, as assigned.
Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical documents as required.

Supports Material Evaluation Process for new materials if required.
Provides project support for new product development which requires a close working relationship directly with Customers as well as suppliers.
Participates in inter-departmental task teams.
Interfaces with peers in other departments, senior management, customers and regulatory agencies.
Provides support for ordering and maintaining inventory of laboratory materials and equipments.
Provides training for new or existing personnel.
Identifies and implements process improvements that will reduce cycle time to test and release products.
Performs other miscellaneous duties as required.
Works flexible hours including weekends and evenings to accommodate the production / validation schedule.

Education: Minimum Bachelor's degree in Analytical Chemistry or related discipline

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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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Sr. Design Researcher

Job Reference: 21-00528 Type: Title: Sr. Design Researcher

Description
Human-centered insights and a deep understanding of people and cultures are critical to how we do our best work. Our team of Design Researchers guide design partners and cross-functional teams at *** to Client, interpret, and communicate insights and opportunities in an inspiring way, while contributing to all phases of the design process.

Were looking for a driven researcher who is radically inspired by people and excels at leading the charge of gathering and communicating insights that put our users at the center of our product thinking. The ideal candidate loves working with peers and leaders to mine for insights that drive elegant solutions to tough problems.

In this role, you will work alongside partners from Design, Product Management, Engineering, Marketing, and other core teams to ensure your research is optimized to develop key insights to drive great experiences. You will also work closely with our team of talented Design Researchers in designing, planning, conducting, and socializing user research across a spectrum of methodologies.

Responsibilities:
Utilize a mixed-methods practice of gathering both generative and evaluative insights. Methods may include: in-lab and field studies, online surveys, usability testing, moderated and unmoderated remote testing, participatory design, customer journey mapping, personas, benchmarking, heuristic evaluations, in-depth user interviews, as well as stakeholder interviews
Establish and maintain an efficient strategy for scoping research, execution, visual storytelling and utilization of findings and artifacts to ensure alignment and action across internal partners
Monitor the impact of insights generated by the team and take part in the always-growing Design Research practice at ***

Qualifications:

- 4+ years of experience in an applied user research setting
- Advanced Degree in Human Factors, Human-Computer Interaction, Cognitive or Experimental Psychology, Cognitive Science, or a related field
- Consistent track record of building and curating a Design Research program, employing a range of methodologies depending on need
- Practical experience in deploying qualitative and quantitative research methods throughout the product development lifecycle, from conceptualization to launch
- Ability to solve complex problems and support the team in delivery of insights
- Strong communication skills, experienced influencer, storyteller, and advocate for user research
- eCommerce/global research experience desired

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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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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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Quality Control Compliance Specialist

Job Reference: 21-00508 Type: Duration:0-6 month(s)

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

- 1st shift 8-5pm

Duration: 6 months

Phone Screen template in help section of IQN. Please use the QC Specialist- Chris Hardin template.

This role is responsible for supporting compliance in the Quality Control Analytical Laboratory, including authoring, management and/or tracking of investigations/events/deviations, Corrective Action / Preventive Action, change control, and other Quality records. This position will facilitate the compiling, trending and reporting of key quality metrics for management accountability, and other quality control functions, as needed. Continuously monitor systems, logbook management, and testing procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.
Responsible for tracking and trending aspects of Quality Control Systems and provide reports to management identifying risks and trends on a routine basis.
Works with Quality Systems group to perform QC CAPA effectiveness evaluation based on quantitative and qualitative measurements.
Maintains tracking mechanisms to support various QC related analytical metrics.
Continuously monitor and review QC systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Provide compliance support and expertise for QC department.
Participate in QC compliance remediation plans and implementation.
Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
Establish and execute laboratory audit readiness program to ensure a compliance ready state at all times in the laboratory.
Participates in QC internal audits, as applicable.
Participate in site quality and process improvement initiatives. Represent QC Analytical on-site project teams.
Provide protocol generation and execution support for critical facility and utility qualifications and startups.
Other duties, as assigned.
Experience with Good Manufacturing Practices (GMPs)
Experience with the development / review / approval of CAPAs / Deviations / Investigations within the pharmaceutical/ biologics industry, especially within the Analytical / Bioanalytical laboratories
Experience with ICH Guidelines / USP / EU GMPs
Ability to quickly learn and navigate electronic systems
Able to work in a team setting and independently under minimum supervision
Requires the ability to work and produce results in a fast-paced environment
Creative individual with excellent trouble shooting skills
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
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 / Compliance function, or significant participation with investigations/deviations/events/etc., within the laboratory setting
Experience with the analytical and/or bioanalytical testing process
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 Analyst

Job Reference: 21-00507 Type: Duration:0-6 month(s)

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

Shift: 8-5pm

Phone Screen Template required. Please use the QC Analyst phone screen template.

"Paragon Gene Therapy is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices 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 Paragon employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
This role is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.
Key Responsibilities include but are not limited to:
Primary responsibility is in Environmental Monitoring in classified cleanrooms. Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.
Conducts testing of utilities such as USP water, clean steam, and testing of other manufacturing environments (air, surfaces)
Builds credibility within the lab group by performing high quality work
Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
Acts as Quality Control authority for aseptic flow and behavior within cleanrooms
Utilizes MODA to enter, compile, and trend environmental data for reporting purposes
Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility
Effectively communicates results of own work through discussions and documentation with some input from supervisor
Flexibility in following unique campaign requirements that may include off-hour and weekend work
May conduct bioburden and membrane filtration testing on cleaning, in-process and release samples.
Experience & Education:
Associates degree in a Life Sciences discipline and 2 years of relevant experience working in cGMP cleanrooms
Experience working in cGMP Quality Control
Experience with Microsoft Excel and Microsoft Word
Strong attention to detail
Familiarity with Good Manufacturing Practices (cGMPs)
Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Must be able to work off hours or weekends as required
LIMS or MODA experience a plus
Experience conducting bioburden and membrane filtration testing a plus
"

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Associate Scientist

Job Reference: 21-00481 Type: Duration:0-6 month(s)

Description/Comment:Associate Scientist - Quality Control
Location: St. Petersburg, FL *work on-site*
Pay rate: *** p/hr
Bill rate: *** p/hr
Mark-up: 45%
Schedule - 1st Shift Mon-Fri; possible Tues-Saturday schedule


The Quality Control laboratory supports testing and release of raw materials, intermediate and finished products, and all critical systems supporting manufacturing operations such as purified and potable water, compressed gases, captive zone environmental analysis, as well as cleaning and process validation support. The department provides analytical services to manufacturing, Technical Services, Validation and new material qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburgs Quality departmental policies. The Associate Scientist II, Quality Control will Independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products. Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines. Communicate results in written and oral presentations. Help in writing Procedures, Specifications and Test Methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group. Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies.

The Role (daily responsibilities)
o Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols.
o Prepares reagents, standards, Medias, etc. needed for analysis.
o May be required to work with potent and teratogenic compounds. o Capable of working under moderate supervision.
o Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks.
o Logs results into GLIMS database o
Required to work shifts in support of the manufacturing process that may include, weekends and holidays. The work hours may change depending on departmental needs.

The Candidate (requirements)
o Requires BS with college course work in related sciences. At least (3) years experience in an analytical laboratory. Must possess good interpersonal skills. Ability to effectively communicate with co-workers. Good organizational skills required o H.P.L.C. and G.C. instrumentation experience Preferred o Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions. o Knowledge of safety and hazardous waste requirements

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Project Manager

Job Reference: 21-00479 Type:
Leads operational project(s) in support of Technical Development of a new product platform within Seqirus. This role will collaborate with TD and Operational resources to develop a plan for process and documentation requirements and other deliverables within the scale up and small scale manufacturing process. Uses project management principles and tools to lead cross functional team members and facilitate the delivery of required tasks. Develops and tracks to schedule and budget.
Skills:

Ability to develop a project plan, project detailed schedule, manage project deliverables and facilitate team meetings and team activities. Ability to prepare regular progress reports and gate review documents as needed to progress the project. Skills in MS Project, Power Point, Excel and Microsoft Office programs.

Education:

Bachelor's in Science or Engineering.

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Administrative Assistant

Job Reference: 21-00478 Type: Job Description: Summary: Provide high-level administrative support by conducting research, handling information requests and performing clerical functions. Education/Experience. High School Diploma or equivalent required. 2 to 4 years experience required. Skills and Competencies: Verbal and written communication skills, multi-tasking, customer service skills and interpersonal skills. Ability to work independently and manage ones time. Ability to keep information organized and confidential. Previous experience with computer applications, such as Microsoft Word, Excel and PowerPoint. Major Job Duties and Responsibilities: Perform general office duties such as ordering supplies, maintaining records management systems, and performing basic bookkeeping work. Prepare invoices, reports, memos, letters, financial statements, and other documents. File and retrieve corporate documents, records, and reports. Open, sort and distribute incoming correspondence, including faxes and emails. Prepare responses to correspondence containing routing inquiries. Perform other duties as assigned.
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