9h ago

Quality Assurance Associate

Philadelphia, PA

โœจ $65k-$85k / yearest.

full-timebiotech

๐Ÿ›  Tech Stack

๐Ÿ’ผ About This Role

You'll own the Quality Management System (QMS) at a biotech company advancing vaccines and antibody therapeutics. You'll ensure ISO 9001 compliance and drive data-informed improvements across the organization. This role offers leadership in audits and certification opportunities.

๐ŸŽฏ What You'll Do

  • Own and maintain the QMS including document control and SOP lifecycle
  • Serve as primary QA representative for internal and external audits
  • Partner with QC personnel to ensure consistent quality standards
  • Manage quality events from investigation through closure
  • Track and report QMS performance metrics for continuous improvement

๐Ÿ“‹ Requirements

  • ISO 9001 working knowledge
  • Hands-on experience with eQMS platforms
  • BS in a scientific discipline (biology, chemistry, engineering, or related)
  • 1-4 years of experience in Quality Assurance or Quality Systems

โœจ Nice to Have

  • GMP/GLP experience
  • Dot Compliance eQMS experience
  • Biotech or pharma industry background

๐ŸŽ Benefits & Perks

  • ๐ŸŽ“ Professional certifications (Quality Auditor, Lean Six Sigma)
  • ๐Ÿ–๏ธ Opportunity to shape quality strategy
  • ๐Ÿ‘ฉโ€๐Ÿ”ฌ Cross-functional collaboration with scientists and auditors

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Recruiter phone screenยท 30 min
  2. 2Hiring manager interviewยท 45 min
  3. 3Technical interview with teamยท 60 min
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