Senior QA Specialist - Biopharma, Flexible, High-Impact

Evotec SE; Redmond (WA); Sur place; USD 110 000 - 126 000; Plein temps

Avantages offerts par ce poste

Flexible work environment

Medical, Dental and Vision

Disability benefits

401k with company match

Paid time off

Résumé du poste

Just Evotec Biologics in Redmond, WA is seeking a QA Senior Specialist to drive quality initiatives and ensure compliance in manufacturing processes. The role emphasizes solving complex problems, collaborating across teams, and coaching junior staff.

The successful candidate will review records, support audits, and monitor process performance, shaping quality outcomes and safety across site operations.

Qualifications

• Bachelor’s degree in biological or engineering science.
• Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment.
• Ability to collaborate and communicate cross-functionally.
• Proven attention to detail.

Responsabilités

• Review executed Manufacturing processing Batch Records.
• Lead compliance walkthroughs of Manufacturing and other assigned areas. Monitor corrections as appropriate.
• Lead the training of new or junior staff.
• Partner with Manufacturing to ensure compliance in Manufacturing operations.
• Triage Manufacturing events and support event investigations.
• Review and approve Master Batch Records, Process Technical Design, and other related documents.
• Support internal and client audits. Present as subject matter expert during audits.
• Execute process performance and product quality monitoring programs.
• Identify potential compliance issues.
• Alert senior management of significant quality, compliance, supply, or safety risks.

Connaissances

Collaboration & communication

Attention to detail

Formation

Bachelor’s degree in biological or engineering science

Description du poste

Just Evotec Biologics in Redmond, WA is seeking a QA Senior Specialist to drive quality initiatives and ensure compliance in manufacturing processes. The role emphasizes solving complex problems, collaborating across teams, and coaching junior staff.

The successful candidate will review records, support audits, and monitor process performance, shaping quality outcomes and safety across site operations.