QA Associate - Quality Assurance - Site Based, Swing Shifts - Starting 12noon.

Evotec•Redmond, WA

1d•$78,000 - $82,000•Onsite

About The Position

Just Evotec Biologics is seeking a curious and collaborative QA Associate to support quality assurance at its Redmond, Washington site. The role works with Manufacturing to ensure compliant operations and supports the company’s Global Quality Management System (G-QMS) and regulatory requirements. The associate reviews manufacturing records and quality documents, participates in compliance walkthroughs, monitors process performance and product quality, and supports quality events and audits. The role also monitors QMS effectiveness through trending, analysis, and metrics, reports KPI performance to management and G-QMS, and represents QA on cross-functional product teams to coordinate stability activities with project milestones. This is a site-based position with a scheduled Sunday-through-Wednesday shift of 10 hours per day, starting at 12 noon and ending at 10:00 p.m., with additional ad-hoc days as business requirements dictate. The expected base pay range at commencement is $78,000–$82,000. The company also describes opportunities for learning and development, flexible work options, an inclusive culture, and work on innovative projects.

Requirements

Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or a related life science field.
Minimum of 2 years of relevant experience in a biopharmaceutical or pharmaceutical cGMP manufacturing or similar environment.
Strong attention to detail.
Ability to collaborate and communicate cross-functionally.

Responsibilities

Review executed Manufacturing Batch Records.
Participate in compliance walkthroughs of the Manufacturing floor and other assigned areas.
Partner with Manufacturing to ensure compliance in manufacturing operations.
Review and approve Master Batch Records and other supporting documents.
Execute process performance and product quality monitoring programs.
Alert senior management to potential deviations or compliance risks.
Initiate and review eQMS quality events, including Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, and Product Quality Review, to ensure compliance with regulatory and Just-Evotec G-QMS requirements.
Support QA QMS in internal and external client audits and regulatory inspections, including serving as a subject matter expert for QMS processes and individual records.
Monitor QMS effectiveness through trending, analysis, and metrics; report KPI performance to top management and G-QMS and identify opportunities for continuous improvement.
Represent QA on cross-functional product teams to integrate stability activities with project milestones.

Benefits

Discretionary annual bonus.
Medical, dental, and vision benefits.
Short-term and long-term disability coverage.
Company-paid basic life insurance.
401(k) company match.
Flexible work options.
Generous paid time off and paid holidays.
Wellness benefits.
Transportation benefits.
Professional courses, mentorship, and new project opportunities for learning and development.