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PDS Tech Inc Quality Assurance Specialist in Berkeley, California

PDS Tech, Inc. is seeking a Quality Assurance Specialist in Berkeley, CA

Position Summary:

  • Evaluate and approve Quality department generated documentation (e.g. batch records and manufacturing process records) using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.

Position Duties and Responsibilities:

  • Review and approve API/finished product batch and manufacturing records using scientific principles.

  • Prepare and release Raw Material used at Berkeley site

  • Perform final inspection of product vials and packaged material to ensure products are free of defects and meets specifications.

  • Determine acceptability or rejection of vial/packaged product and take necessary steps to remediate potential issues (e.g., halting the production process).

  • Represent QA in interactions with Manufacturing, QA, QC, Supply Chain and Regulatory inspections.

  • Enter, review and query data in electronic systems (e.g., BASICS, Dev@com, LIMS) to support lot release activities.

  • Write and revise SOP’s;

  • Review and approve of specific area documentation (e.g., change control, deviation) using scientific principles as needed.

Qualifications:

  • Bachelor's degree in a Science or Technical field (minimum education required; Include degree and concentration)

  • Must be fully vaccinated

Skill & Competency Requirements:

  • At least six years of experience in the biopharmaceutical, has general knowledge of the techniques used in other disciplines in the QC department and has a general understanding of how results from each discipline impact the quality of the drug substances manufactured

Preferences:

  • 20/20 vision

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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