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QA Specialist

  • Location: New Brunswick
  • Job Type:Contract

Posted 11 days ago

  • Expiry Date: 16 December 2022
  • Referral: 219930@accuick.com

Job 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.

  • You 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.

Responsibilities:

  • 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 assist 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 ensure CMO is compliant with company 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.

Qualifications:

  • 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 ensuring 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.