QA Senior Specialist - Site Based, Redmond, WA - Swing Shifts from 12noon
About The Position
Just Evotec Biologics is seeking a curious and passionate QA Senior Specialist to join its Quality team in Redmond, Washington. This site-based role supports quality and compliance in biopharmaceutical manufacturing through batch record and document review, compliance walkthroughs, event investigation support, audit participation, and process and product quality monitoring. The specialist partners with Manufacturing, trains new or junior staff, and raises significant quality, compliance, supply, or safety risks to senior management. The position is scheduled Sunday through Wednesday for 10-hour shifts starting at 12 noon and ending at 10:00 p.m., with additional ad hoc days as business requirements dictate. The stated base pay range at commencement is $110,000 to $126,400; the salary offered may vary based on skills, experience, and market value. Additional total rewards include a discretionary annual bonus, benefits, paid time off, paid holidays, wellness benefits, and transportation benefits.
Requirements
- Bachelor’s degree in biological or engineering science.
- At least 5 years of relevant experience in a biopharmaceutical or pharmaceutical cGMP manufacturing environment, or a similar environment.
- Ability to collaborate and communicate cross-functionally.
- Proven attention to detail.
Responsibilities
- Review executed Manufacturing processing batch records.
- Lead compliance walkthroughs of Manufacturing and other assigned areas and monitor corrections as appropriate.
- Lead training for 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 and present as a subject matter expert during audits.
- Execute process performance and product quality monitoring programs.
- Identify potential compliance issues.
- Alert senior management to significant quality, compliance, supply, or safety risks.
Benefits
- Growth and development opportunities, including professional courses, mentorship, and new projects.
- Flexible work options; the role itself is site-based.
- Discretionary annual bonus.
- Medical, dental, and vision benefits.
- Short-term and long-term disability coverage.
- Company-paid basic life insurance.
- 401(k) company match.
- Generous paid time off and paid holidays.
- Wellness benefits.
- Transportation benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
