Quality Management Systems Specialist

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.