Just Evotec Biologics

Biopharmaceutical

QASpecialist

$87–87k Redmond, Washington, United States FULL TIME
The Brief

“QA Specialist at Just Evotec Biologics. Skills: GMP manufacturing, Quality assurance, Compliance. Execute day-to-day QA responsibilities for GMP manufacturing. Build and enhance quality assurance systems”

What You'll Achieve.

Ensure compliance with cGMPs; Ensure compliance with internal procedures; Alert senior management of risks

Industry & Context.

Biopharmaceutical
Problems you'll solve

Solving complex problems; Find creative solutions

Eligibility Requirements

Site Based, Days 07:00 till 16:00, Tue to Sat or Sun to Thurs

What They're Looking For.

Must Have

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

What You'll Do.

Execute day-to-day QA responsibilities for GMP manufacturing

Build and enhance quality assurance systems

Ensure compliance with cGMPs and internal procedures

Review executed Manufacturing Batch Records

Execute compliance walkthroughs

Participate in training of new staff

Partner with Manufacturing for compliance

Triage Manufacturing events

Support event investigations

Review and approve Master Batch Records

Support internal and client audits

Execute process performance monitoring

Execute product quality monitoring

How You'll Work.

Team & Collaboration

Collaborate with Manufacturing, Quality and Facilities staff; Partner with Manufacturing to ensure compliance; Collaborate cross-functionally

Communication Scope

Communicate cross-functionally

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