QA Senior Specialist - Compliance

We are seeking a Quality Assurance Compliance Senior Specialist to join our clients team!

Key Responsibilities:

• Review and approve quality agreements.
• 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.
• Support OpEx programs and champion continuous quality improvement initiatives.
• QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:
• Change controls
• Deviations/Investigations
• CAPAs
• Other associated documentation

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.