Position Summary
We are seeking to recruit a contract Senior Specialist, QA Compliance. Reporting to the Senior Manager, QA Compliance, the Senior Specialist, QA Compliance will support supplier quality operations.
Key Responsibilities
• Release incoming materials for use in manufacturing operations
• Support qualification of new suppliers/materials and requalification of existing.
• Assess supplier change notifications for impact to qualification status.
• Support material certification and direct dispense programs.
• Review and approve quality agreements.
• Authoring, review and approval of QA-related procedures.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
o Change controls
o Deviations/Investigations
o CAPAs
o Other associated documentation
• Support OpEx programs and champion continuous quality improvement initiatives.
Qualifications & Experience
BSc in Science or related discipline with a minimum of 2 years’ Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
Detailed knowledge of Biologics Processing would be a distinct advantage.
Required to work on his/her own initiative in addition to working as part of a team. Excellent communication, presentation, time-management and organizational skills are essential.
