QA Specialist - Lot Disposition, Site Based, Redmond, WA
Evotec
Summary
Just-Evotec Biologics is seeking a highly motivated QA Specialist that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The role incumbent works both independently and collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures.
Job description
What You'll Do
- Compile lot release documentation for product disposition
- Ensure lot release deliverables are received from key stakeholders prior to Product disposition
- Facilitate weekly lot disposition meeting with QA, Manufacturing, QC, etc
- Review Deviations, OOS, and Change control records to ensure no impact to Product
- Partner with other QA peers to ensure consistency and efficiency within the QA department
- Alert senior management of significant quality, compliance, supply, and safety risks
Who You Are
- Candidate must possess strong focus on right the first time and attention to detail
- Possess effective task/time management organizational skills
- Capacity to develop solutions to technical issues of moderate scope
- Ability to organize, analyze/interpret, and effectively communicate individual results
- Motivated, self-starter with strong mechanical aptitude
- Good interpersonal, team, and communication skills are a must
- Excellent oral and written communication skills
Qualifications
- Bachelor's degree in biological or engineering science
- Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
- Ability to collaborate and communicate cross-functionally
- Proven attention to detail
Requirements
- Bachelor's degree in biological or engineering science
- Minimum of 3 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
- Ability to collaborate and communicate cross-functionally
- Proven attention to detail
- Strong focus on right the first time and attention to detail
- Effective task/time management organizational skills
- Capacity to develop solutions to technical issues of moderate scope
- Ability to organize, analyze/interpret, and effectively communicate individual results
- Strong mechanical aptitude
- Good interpersonal, team, and communication skills
- Excellent oral and written communication skills
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Flexible PTO
- Paid Holidays
- Wellness Benefits
- Transportation Benefits
- Discretionary Annual Bonus
Company overview
Evotec SE is a leading German drug discovery and development partnership company headquartered in Hamburg, Germany. Founded in 1993 by Nobel Laureate Manfred Eigen and other scientists, Evotec operates as a contract research organization (CRO) that collaborates with pharmaceutical companies, biotechs, academic institutions, and government agencies to advance therapeutic innovations. The company employs approximately 4,788 professionals worldwide and specializes in small molecule drug discovery across multiple therapeutic areas including oncology, neurological disorders, metabolic diseases, cardiovascular conditions, inflammation, pain, and respiratory diseases. Evotec's comprehensive service portfolio encompasses target identification and validation, hit identification, in vitro pharmacology, integrated CMC services, and proteomics. With facilities across Europe and the United States, the company has established long-term strategic alliances with major pharmaceutical partners including Bristol Myers Squibb, Bayer, Sanofi, Boehringer Ingelheim, and Eli Lilly. Evotec's innovative Pipeline Co-Creation model represents a flexible, multi-modality approach to drug development, leveraging data-driven disease understanding and AI technologies to accelerate the delivery of quality drug candidates.