Technical Writer; Life Sciences
Listed on 2026-07-26
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Quality Engineering
Now Hiring:
Technical Writer - Specialist, Quality Management Systems (QMS)
Are you passionate about quality, investigations, and technical writing in a GMP environment? We're looking for a Technical Specialist, QMS to join a growing biopharmaceutical manufacturing team. In this role, you'll play a key part in ensuring compliance by investigating quality events, writing detailed technical reports, and driving continuous improvement.
We're looking for candidates with:
B.S. degree in science or engineering (biological, chemical, or biomedical.
2+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
Experience with writing QMS documents preferred.
Experience investigating deviations, CAPAs, OOS, OOT, or other quality events.
Experience with Veeva Quality Management Systems (QMS) is a plus.
What you'll do:
- Investigate quality events, including deviations, OOS, OOT, OOL, and calibration issues.
- Conduct root cause analyses and document findings in the Quality Management System (QMS).
- Write clear, accurate, and GMP-compliant technical reports and investigation records.
- Collaborate with Manufacturing, QA, QC, Engineering, and other cross-functional teams to gather information and resolve quality issues.
- Recommend and track Corrective and Preventive Actions (CAPAs).
- Manage investigations from initiation through approval and closure while meeting established timelines.
- Identify opportunities to improve processes and strengthen quality systems.
- Health, dental, vision insurance, 401(k) matching, and paid time off.
- Work on impactful products in a regulated, high-quality environment
- Collaborate with cross-functional global teams
- Grow your career in a dynamic and innovative organization
Work Authorization:
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
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