QA Specialist - Lot Disposition, Site Based, Redmond, WA
About The Position
At Just Evotec Biologic ., we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated. 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.
Requirements
- 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
- 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.
Nice To Haves
- Proven attention to detail
Responsibilities
- 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.
Benefits
- Medical
- Dental
- Vision
- 401k company match
- flexible paid time off
- paid holiday
- wellness benefits
- transportation benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
