Job Reference: 21-00507
Type: Duration:0-6 month(s)
Description/Comment:Pay Rate: ***/hr
Bill Rate: ***/hr
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
Quality Assurance Analyst Lead
Job Reference: 20-08541
Type: Job Description: Designs and implements test strategy, test plan, testing scenarios and testing scripts for testing applications using industry accepted methodologies and procedures. Detects and logs errors into defect tracking tool, recreating them as needed. Works with developers to identify root cause and track errors through to resolution (including validation with customers) and escalates issues when appropriate. Works closely with QE engineers, developers and business teams to correctly interpret business requirements and technical documentation. Participates in review of requirements, system concept discussion and functional and technical design documents to appropriately plan, design and execute on quality assurance activities. Provides testing requirements to test support teams (data, batch and environment). Develops and implements quality assurance standards, processes and procedures based on the Agile SLDC and Scrum Methodology. Works with the development management team and project managers on resource and schedule issues.
Evaluates production readiness of project delivery by validating and documenting the completion of testing and development. Provides comprehensive reporting of testing progress and defects to provide visibility to project team.
Process Control Engineer
Job Reference: 20-08066
Type: Description/Comment:Summary: The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings, and read and interpret blueprints. Job Responsibilities: Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency. Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards. Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications. Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays. Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization. Skills: Creativity, verbal and written communication skills, analytical and problem solving ability. Team player and detail oriented. Ability to make sketches, engineering drawings and common computations. Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports. Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD). Education/Experience: Bachelor's degree in engineering required. 2-4 years experience required.
Analytical Data Auditor R&D
Job Reference: 20-07702
Type: Duration:0-6 month(s)
Description/Comment:Job Title: Analytical Data Auditor R&D
Location: St. Petersburg, FL
Shift - 8am-5pm Mon-Fri with opportunity for overtime
Duration: 6 months or longer
Max bill rate: *** Max mark-up: 45%
I. Department Overview:
The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, and in-process and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of products and materials. The department provides analytical services to manufacturing, process development, validation, and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also supports CMC development activities in support of client regulatory filings. Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburgs Quality departmental policies.
II. Basic Function:
Independently review and audit analytical data including notebooks, chromatographic data, validation protocols and reports and other analytical data protocols and reports. Document and communicate results both to the analysts whose work is under review and to laboratory management when required. Maintain proper records in accordance with all SOP's and policies.
III. Specific Activities, and Responsibilities:
Perform audits of analytical data to include but not limited to laboratory notebooks, chromatographic raw data, analysis reports, and other analytical data as required, against test methods, specifications, and other reference documents.
Initiate/facilitate/review documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to data quality.
Approve analytical documents as the reviewer against applicable specifications/procedures.
Perform data certification in the electronic LIMS system if applicable.
Actively participate in corrective actions and continuous improvements.
Assist in complying with any other company and /or departmental objectives as directed by AR&D management.
Deliver on commitments to meet customer expectations.
All other duties as assigned.
IV. Knowledge Requirements:
Education or Equivalent:
Requires a minimum of: MS in scientific field with 3 plus years, or BS in scientific filed with 5years or AS in scientific filed with 10 years in the analytical lab
Analytical laboratory / Pharmaceutical and or GMP experience preferred
Prior quality assurance experience with CMC review is preferred.
Working knowledge of cGMPs regulations.
Certified Quality Auditor is a plus.
Must possess good interpersonal skills.
Ability to effectively communicate with co-workers.
Good organizational skills required.
Excellent oral and written communication skills.
Proficient in Microsoft Office. Good word processing skills.
Motivated, self-started, team player.
Ability to identify problems.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work effectively under pressure to meet deadlines.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Be accessible to manufacturing, laboratory and office staff.
Be able to use required office equipment.
Vision requirements include reading of English documents and distinguish color.
Ability to work extended hours or off-hours as required.
Stationed in either office or laboratory environment with moderate noise level
Required to wear proper PPEs when auditing equipment and log books
IT Quality Assurance Engineer
Job Reference: 20-06632
Type: Duration:0-6 month(s)
Job Reference: 19-13632
Type: Duration:0-6 month(s)
Description/Comment:The Incident Management team's mission is to ensure timely resolution of all ***'s incidents by owning, developing and enhancing the global Incident Management process, driving Major Incidents to resolution and providing a standardized, repeatable mechanism to achieve resolution of all incidents affecting ***'s products, services, and revenue.
We are in a 24X7 work environment looking for highly motivated individuals to drive the resolution of any service-impacting incident within the Global *** Infrastructure. This position requires an aggressive task-oriented individual who can multitask on problems of varying difficulty, priority and sensitivity in order to keep each of our brands users seeing limited impact during faults. If you are an individual who thrives on technology and enjoys tackling unforeseeable challenges in a fast-paced environment, we want to hear from you!
Coordinating and driving technical incident resolution, working closely alongside operations, service engineering, and development teams
Understanding complex technical problems and effectively communicating business impacting issues and triage status to executive leadership and stakeholder groups
Defining and maturing incident management processes, best practices, and the function itself
Identifying and documenting process breakdowns that exacerbated or caused the impact
Responsible for performing Incident Management functions as prescribed by the Incident Management Team within the standard operating practices and processes of ITIL service operation framework
Partner with internal/external teams on operational issues
Dispatching on-call engineers, facilitating communication and driving resolution to events via standard operating procedures
Maintaining service level agreements, tracking escalations, and managing key performance indicators
Working effectively with peers through team participation and cohesiveness to create a positive environment within the team
Performing quality assurance activities to help ensure accuracy in peers work
Identify and develop solutions to problems within our tools, processes and partnerships
Execution and coordination of complex project assignments which may have direct impact on our team and/or partnerships
The ideal candidate will have application and network troubleshooting skills, IT service management skills, excellent written and verbal communication capabilities and the ability to multitask in order to facilitate the resolution of multiple incidents at any given time with the vision to automate in order to better scale and streamline process.
A bachelor's degree in a computer-related field or equivalent knowledge and experience in role
Ability to break down complex incidents into smaller actionable components and develop a roadmap to incident equivalent
Experience working as an Incident Manager
Strong verbal and written communication skills for documenting and communicating incidents in real-time
Ability to clearly communicate and translate business impacting issues to executive leadership
Strong organizational skills with the ability to multitask in order to handle concurrent business demands in a real-time environment
Understanding of the network environment
Requires successful completion of level 2 security clearance
2-3 years experience working in an organization that has implemented ITIL standards
2-3 years experience working on an incident management team
1-2 years experience working in a Technical Call Center, NOC, or equivalent environment
Knowledge of ITIL Service Lifecycle phases, framework, and best practices
Knowledge of LAMP, DNS, NFS, TCP/IP, BGP, and other Internet protocols
Knowledge of basic Unix diagnostic tools and commands
Knowledge of Data Center Facilities and IT Services equipment
Certifications, e.g., RHCT, ITIL, CCNA, PMP or equivalents are a plus