9h ago
Quality Assurance Associate
Philadelphia, PA
โจ $65k-$85k / yearest.
full-timebiotech
๐ Tech Stack
๐ผ 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.
๐ฏ 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
๐ 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
โจ Nice to Have
- GMP/GLP experience
- Dot Compliance eQMS experience
- Biotech or pharma industry background
๐ Benefits & Perks
- ๐ Professional certifications (Quality Auditor, Lean Six Sigma)
- ๐๏ธ Opportunity to shape quality strategy
- ๐ฉโ๐ฌ Cross-functional collaboration with scientists and auditors
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter phone screenยท 30 min
- 2Hiring manager interviewยท 45 min
- 3Technical interview with teamยท 60 min
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