QA Senior Specialist - Site Based, Redmond, WA
Evotec
17 days ago
On-site
Redmond, WA
Operations
Responsibilities (QA Operations)
- Review executed Manufacturing processing Batch Records.
- Lead compliance walkthroughs of Manufacturing and other assigned areas; monitor corrections as appropriate.
- Lead 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.
Qualifications
- Bachelor’s degree in biological or engineering science.
- Minimum 5 years relevant experience in biopharmaceutical/Pharmaceutical cGMP manufacturing (or similar environment).
- Ability to collaborate and communicate cross-functionally.
- Proven attention to detail.
Benefits
- Base pay range: $110,000 to $126,400.
- Discretionary annual bonus; Medical, Dental and Vision; short-term and long-term disability; company paid basic life insurance; 401k company match; flexible work; paid time off and paid holiday; wellness and transportation benefits.
Application instructions
- Apply today.
- Review executed Manufacturing processing Batch Records.
- Lead compliance walkthroughs of Manufacturing and other assigned areas; monitor corrections as appropriate.
- Lead 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.
Qualifications
- Bachelor’s degree in biological or engineering science.
- Minimum 5 years relevant experience in biopharmaceutical/Pharmaceutical cGMP manufacturing (or similar environment).
- Ability to collaborate and communicate cross-functionally.
- Proven attention to detail.
Benefits
- Base pay range: $110,000 to $126,400.
- Discretionary annual bonus; Medical, Dental and Vision; short-term and long-term disability; company paid basic life insurance; 401k company match; flexible work; paid time off and paid holiday; wellness and transportation benefits.
Application instructions
- Apply today.