Associate Scientist / Quality Control Analyst (Cell Based Potency Assays) in Irvine, CA

Onsite

• The Quality Control Analyst is responsible for conducting the cell-based potency assays(CBPA) of biologics for release and stability of both commercial and late-stage biologics under current good manufacture practice(cGMP).
• He/She will prepare all documentation associated with the cGMP testing and independently or in a team setting execute protocols in support of manufacture of Client biologics product.
• The position is responsible for cGMP compliance of the quality control CBPA laboratory, ensuring that all cell Based Potency Assays testing is performed according to the FDA, foreign MOH and Client requirements.

Major Responsibilities:

• Perform cGMP testing in support of the manufacture of Client biologics products.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Perform and execute activities supporting CBPA lab such as equipment validation, equipment preventive maintenance.
• Generate and update SOPs.

Regulated Responsibilities (including cGMP and EHS):

Client is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to:

• The FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA. Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications:

• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.
• Proficiency in TrackWise, Microsoft Project, and Excel.
• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ELISA preferred.
• Experience with aseptic cell culture and cell banking preferred.

What are the top 3-5 skills, experience or education required for this position:

1. MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.
2. Experience in a cGMP regulated environment required.
3. Experience with the application of aseptic cell culture and 96-Well format bioassay techniques for potency determination of proteins and their degradation and modification products

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