Quality Management Specialist

Location: Piscataway, NJ

Under the guidance of Manufacturing Management, the QMS Specialist will play a pivotal role in supporting documentation activities within manufacturing operations. This includes authoring, reviewing, and managing deviations, change controls, investigation reports, batch records, SOPs, and CAPAs. The ideal candidate will bring expertise in upstream and downstream biologics processes, particularly in cytokines and monoclonal antibody manufacturing.

• Support the manufacturing team with all aspects of documentation.
• Review executed batch records (Upstream and Downstream processes).
• File and manage change controls, deviations, and CAPAs for the manufacturing department.
• Conduct critical/major investigations using tools like 5-Why or 6M method.
• Participate in daily process meetings (Upstream and Downstream) to identify and prioritize documentation needs.
• Collaborate with QA to ensure timely QMS documentation closure.
• Author and maintain batch records, SOPs, and associated manufacturing forms.
• Handle GMP document requests and submissions to QA.
• Support critical manufacturing campaigns, including during shift processes.
• Perform up to 10% wet lab work as needed.

• Education: BA or BS in Biological Sciences or a related technical field.
• Experience: Minimum of 5 years in Biopharmaceutical manufacturing.
• Technical Expertise: Knowledge of Upstream (USP) and Downstream (DSP) biologics processes.

• Proven ability to work collaboratively and independently within cross-functional teams.
• Strong communication skills (written and verbal), excellent organization, and attention to detail.
• Proficient in Microsoft Word, Excel, and other documentation tools.
• Solid understanding of GMP documentation processes, cleaning verification/validation, and batch manufacturing workflows.
• Experience with deviation management, CAPA systems, and QMS tools.

This is an exciting opportunity to be part of a forward-thinking team dedicated to advancing biologics manufacturing. If you're passionate about QMS, GMP compliance, and supporting cutting-edge biopharma processes, this role is for you.

Apply today to take the next step in your career!