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QA Compliance Specialist

Wayne Metro Area, NJ

Posted: 09/07/2018 Job Type: Scientific Job Number: JN -092018-22487
Description:
  • Coordinate / Support the audit function for vendors, suppliers, service providers and contracts.
  • Coordinate / Support the communication of the audit schedule and executing to plan as required by local procedures and regulatory requirements.
  • Support in external audits; provide written reports and observations in a timely manner and assure correctives are adequate and timely. Support the AQWA FURP and QARP Coordination for the Morris Plains facility as needed with external audits.
  • Manage / Support the vendor change notification/implementation program.
  • Support local Principle Investigator (PI) certification
  • Support on quality manual implementation teams in area of technical expertise as required.
  • Participate / Coordinate internal audits.
  • Support regulatory agency inspections, by way of auditing, training and preparation, and tracking commitments.
  • Assist and participate in regulatory inspection activities as required.
  • Work with site personnel to ensure completion of all regulatory commitments.
  • Support maintenance of central file for correctives and inspection history.
  • Coordinate / participate in the training of personnel on local auditing practices and any corporate policy / standards as required.
  • Coordinate / Support the approval process for new vendors / materials.
  • Coordinate / Support the Raw Material Review Board and Raw Materials Vendor Changes meeting.
Skills:
5+ years of related pharmaceutical experience to include cell gene therapy preferred. Quality Assurance, packaging, manufacturing, auditing and / or technical report writing experience also preferred.
Bachelors or higher in Chemistry, Pharmacy, Microbiology or other related science or work experience.


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