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Senior QA Consultant (cGMP – Pharmaceutical) JD818626

JD818626

DPS is seeking an established and knowledgeable Senior Quality Consultant to support a BioPharma client in the Boston, MA area. Successful candidates should have previous experience managing deviations, CAPAs, CCRs, CMOs, and Aseptic Fill Finish operations. This individual will be responsible for providing supervision/management of all QA activities (i.e. remediation, Investigations, Quality Oversight, Record Review, QMS Support, and Compliance Audits). Occasional travel will also be required in this role.

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
8+
Date Posted:
01/10/2019
Days Remaining:
39
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior QA Consultant (cGMP – Pharmaceutical)                JD818626

Boston, MA area

 

DPS is seeking an established and knowledgeable Senior Quality Consultant to support a BioPharma client in the Boston, MA area.  Successful candidates should have previous experience managing deviations, CAPAs, CCRs, CMOs, and Aseptic Fill Finish operations. This individual will be responsible for providing supervision/management of all QA activities (i.e. Investigations, Quality Oversight, Record Review, QMS Support, and Compliance Audits).

 

Occasional travel will also be required in this role.

 

Responsibilities:

  • Assure that manufacturing operations are in compliance with cGMP regulations.
  • Lead investigations on bulk product manufactured at client site.
  • Provide quality oversight over CMO filling and packaging sites.
  • Act as primary interface with CMOs to guide investigations and ensure client requirements are met.
  • Ensure timely review of batch production records, quality investigations, and CoAs and assure that lot packages are compiled according to procedures.
  • Interface with Production Planning to understand the production and release schedule and make commitments for quality releases.
  • Support management of Quality Management System to support Clinical Trials.
  • Disposition of drug substance and final drug product of clinical products.
  • Conduct of compliance audits as required (Internal, CMO).
  • Provide training and development of QA staff.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • Minimum of 8+ years of Quality Assurance experience in the biotechnology or pharmaceutical industries.
  • Must have demonstrated understanding of cGMP.
  • Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
  • Outward-facing role. Strong communication and interaction abilities are required.
  • Must be able to demonstrate exceptional “critical-thinking” skills and an ability to act collaboratively to provide guidance and leadership on problems as they arise.
  • Ability to serve on multiple interdepartmental teams and to act as team leader when necessary.
  • Proven ability to manage projects while meeting all deliverables and timelines.
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