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Quality Assurance Specialist

New Brunswick, NJ

Posted: 11/15/2022 Job Number: 22374258

Job Description

This candidate must be able to work onsite at either New Brunswick, Devens or Summit West. 100% on site.

Required Skills:
  • BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
  • Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company.
  • Must be fluent in English language.
  • Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
  • Ability to Coordinate Quality oversight and working with other site groups.
  • Ability to review Quality documents and ensure compliance to GMP.
  • Documents to include batch records, logs, and others.
  • Ability to be an effective communicator to Management, and line staff.
  • Ability to work with other manufacturing teams to implement business objectives.
  • Must be very detail oriented and be able to quickly detect errors within documentation.

Project Description:
  • This role is an 18-to-24-month opportunity to gain experience with Bulk Drug Substance manufacturing.
  • The Senior Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support.
  • The incumbent will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release.
  • This position may also be cross trained to cover other QA functions as needed.
  • Provides oversight for CMO Batch Production Records.
  • Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
  • Assists with Document Control and other QA functions.
  • Coordinates and assists in timely review of documentation associated with manufacturing at CMO site.
  • Assists with preparation for FDA and other regulatory agency audits and inspections.
  • Provides daily summaries and follows the completion of CAPAs from audit findings.
  • Gives guidance to CMO as needed and ensures CMO is compliant with the Client's Quality standards.
  • Ensures that all audit items are resolved.
  • Supports site for Inspection.
  • Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time.
  • Escalates critical quality problems to Senior Management in a timely manner.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jacqueline: jacqueline@alphaconsulting.Com


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Jacqueline Sanchez

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