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Philadelphia, United States Randstad Life Sciences US Full time

- 3 openings (2 first shift, 1 second shift)

  • 1st shift, Monday-Friday. Hours are 8:00am-4:00pm.
  • 2nd shift, Monday-Friday. Hours are 1:00pm-9:00pm. **Will be on 1st shift for training for 8-12 weeks before moving to 2nd shift.**

- 6 month contract (very good potential to extend/convert)

- 100% on-site

- MUST have at least 2 years experience in a GMP laboratory. Must have experience with laboratory equipment (especially pipettes).

- Looking for candidates with cell culture experience in an aseptic environment (clean room, aseptic technique) and who have experience with bioassays and potency assays.

- Experience with flow cytometry a huge plus (they use 4 color; basic flow assay).

- BS degree required. Degree in a Biological science is strongly preferred.


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Summary

The Quality Control Specialist will be responsible for the following:

  • Perform daily GMP Quality Control laboratory testing activities
  • Perform data analysis and result reporting to support product lot release with adherence to turnaround times.
  • Support method transfers and method validation testing
  • Support generation and revision of documentation, such as SOPs, protocols and reports, deviations, laboratory investigations, CAPAs and change controls.
  • Support technical problem solving for issues pertaining to GMP QC activities
  • Support product stability programs including execution of stability testing and stability data analysis
  • Perform peer review and or technical review of laboratory data and logbook
  • Responsible for reagent inventory and equipment cleaning and maintenance

Key Responsibilities:

  • Execution of In-process, finished product, and stability samples (60%)
  • Support method qualifications, technology transfer and method validations (10%)
  • Author/Revise SOP’s and Test Methods, Deviations, CAPA’s and Change Controls (20%)
  • Responsible for inventory and instrument/equipment maintenance (10%)

Qualifications

  • Bachelor’s degree in molecular biology, biomedical sciences or related specialties
  • Minimum of 2 years experience in the pharmaceutical industry working in a GMP quality control laboratory
  • Experience with cell culture, aseptic technique, cell-based potency assays, and flow cytometry
  • Proficient knowledge of GMP regulations including USP and EP testing requirements
  • Intermediate experience conducting time critical testing of in-process and finished product to meet in process manufacturing needs
  • Ability to author, review and maintain test methods, qualification protocols, SOPs and reports
  • Conduct laboratory investigations, complete deviations, CAPAs and change controls as needed
  • Ability and desire to effectively work in an interdisciplinary team environment and to effectively interact at multiple levels within the company to support internal manufacturing capabilities
  • Technical writing skills for drafting equipment and laboratory standard operating procedures
  • Ability to follow instructions provided by SOP’s and to document results clearly and in a timely manner following performance of tasks
  • Ability to work as a member of team where combined contribution, collaboration, and time bound results are expected.

Preferred:

  • 3+ years of experience in the pharmaceutical industry within a GMP Quality Control role; experience with cell therapy products is a plus
  • Ability to identify and implement continuous improvement projects for lab process efficiencies
  • Ability to identify and escalate defects for troubleshooting and solution.
  • Ability to work on assigned projects independently with limited supervision.
  • Communicate effectively with team members and the ability to work cross functionally