The Manufacturing QMS Specialist will play a critical role in ensuring smooth and compliant manufacturing operations by managing essential documentation processes. The position requires hands-on expertise in both Upstream (USP) and Downstream (DSP) biologics manufacturing processes, including cytokine and monoclonal antibody production.
Key Responsibilities:
- Act as the main support for the manufacturing team regarding all documentation needs.
- Review and manage executed batch records for upstream and downstream processes.
- File and oversee change controls, deviations, and CAPAs for the manufacturing department.
- Lead critical investigations using tools like 5-Why analysis and 6M methods.
- Attend daily process meetings (upstream/downstream) to prioritize documentation tasks.
- Collaborate with QA weekly to ensure timely QMS closures.
- Author batch records, SOPs, and necessary forms for manufacturing processes.
- Manage GMP document submissions and requests to QA.
- Provide hands-on support during critical manufacturing campaigns, including shift coverage.
- Conduct 10% wet lab work as needed.
What You Bring:
- Education: BA/BS in Biological Sciences or a related technical field.
- Experience: A minimum of 5 years within biopharmaceutical manufacturing.
- Strong technical knowledge of Upstream (USP) and Downstream (DSP) biologics processes.
- Experience with GMP batch documentation, cleaning verification/validation, and audit preparation.
Skills & Attributes:
- Ability to work collaboratively within a team and independently.
- Exceptional written and verbal communication skills.
- Strong attention to detail with excellent organizational abilities.
- Proficiency in Microsoft Word, Excel, and other documentation tools.
- Solid problem-solving skills with experience using structured investigation tools.
