QA Compliance Specialist
Wayne Metro Area, NJ
- 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.
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.