QA Associate — Biopharma Quality & Compliance

Evotec SE

Redmond (WA)

On-site

USD 78,000 - 82,000

Full time

4 days ago
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Benefits offered by this job

Growth opportunities
Flexible work environment
Inclusive culture
Competitive benefits

Job summary

Just Evotec Biologics in Redmond, WA is seeking a QA Associate to join the Quality Department. You will review batch records, support QA/QMS activities, and partner with Manufacturing to ensure compliance across operations.

This role offers growth opportunities and a collaborative, cross-functional environment. The ideal candidate has a bachelor’s degree in a life science field and at least 2 years in a biopharmaceutical manufacturing setting, with strong attention to detail and communication

Qualifications

  • Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or related life science field.
  • Minimum of 2 years relevant experience in a biopharmaceutical/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 walkthrough 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 of potential deviations or compliance risks.
  • Initiate and review all quality events of eQMS to assure compliance with regulatory and Just-Evotec Global Quality Management Systems.
  • Support QA QMS in internal and external client audits and regulatory inspections.
  • Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on KPIs.
  • Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.

Skills

Attention to detail
Cross-functional collaboration
Biopharmaceutical manufacturing
Quality systems

Education

Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, or related life science field

Job description

Just Evotec Biologics in Redmond, WA is seeking a QA Associate to join the Quality Department. You will review batch records, support QA/QMS activities, and partner with Manufacturing to ensure compliance across operations.

This role offers growth opportunities and a collaborative, cross-functional environment. The ideal candidate has a bachelor’s degree in a life science field and at least 2 years in a biopharmaceutical manufacturing setting, with strong attention to detail and communication

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