QC Specialist-Raw Materials

Princeton, NJ

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Type: Contract-to-Hire

Experience: 3

Category: Scientific & Clinical

Brand: Joule

Job ID: 290773

Date Posted: 11/01/2022

Start Date: 09/27/2022

End Date: 05/05/2023

Shortcut: http://jobs.systemoneservices.com/fXIYXZ


Title: QC Specialist

Location: Princeton, NJ

Schedule: 1st shift (Monday-Friday)

Type: Temp to Hire

Start date: ASAP

Exciting opportunity to join a growing biomanufacturing company!

Responsibilities:

  • Responsible for performing routine and specialized analytical/compendia testing of raw materials in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
  • Responsible for working in a team atmosphere and meeting the needs of internal, as well as external customers
  • Will support the inspection, sampling and batch record review of raw materials for clinical and commercial cell therapy products
  • Performs routine and specialized raw material testing (including IR/Raman spectroscopy, wet chemistry analysis, osmometry) according to Standard Operating Procedures and Pharmacopeia methods, in compliance with cGMP.
  • Participates in method transfer/qualification/verification of test methods, new instruments, method qualifications
  • May prepare sample shipments and submission paperwork for contract laboratory testing.  Reviews data received from contract lab for cGMP compliance.
  • Records, analyzes, and reviews all data related to testing. Performs project related tasks as assigned with general instructions.
  • Writes OOS (Out of Specification) /deviation investigations, change controls and CAPA.
  • Writes/revises Standard Operating Procedures (SOPs), validation/qualification/verification protocols and reports for test methods.
  • Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies. Maintains compliance with all required training
  • Perform inspection and sampling of raw materials, commercial and clinical biopharmaceutical products
  • Performs raw material assays to ensure results are passing per specifications.
  • Review and provide Quality approval for electronic and paper incoming material receipt records, and GMP documentation such as work orders, investigation reports, deviation records, and other GMP records
  • Internal Quality Control support for creation and revision of GMP procedures including document review, approval, and archival
  • Support investigations/deviation reports for warehouse operations, incoming raw material receipts

Requirements:

  • BS degree in Life Sciences required
  • 4+ years exp. within the biologic, biopharmaceutical, or regulated industry
  • Exp. supporting raw material testing
  • Exp. in cGMP environment
  • Exp. in a scientific laboratory
  • Demonstrated knowledge in biological, cell based assays including flow cytometry
  • Exp. in QC of cells from human tissue origin
  • Knowledgeable and/or exposure to aseptic manufacturing processes including microbial and cell culture, and fill/finish
  • Exp. with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs

 

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.


System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


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