QA Specialist - Lot Disposition, Site Based, Redmond, WA

Evotec•Redmond, WA

22h•$90,000 - $100,000•Onsite

About The Position

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.
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.