Quality Management Systems Specialist

This position involves managing key documentation processes within a dynamic manufacturing operations team in Piscataway, NJ. The role requires expertise in upstream and downstream biologics manufacturing processes, including cytokines and monoclonal antibody production. Responsibilities include creating, reviewing, and maintaining critical documentation to support compliance and operational excellence in a biopharmaceutical environment.

Responsibilities:

• Provide comprehensive documentation support, including reviewing executed batch records for both upstream and downstream processes.
• Prepare and manage change controls, deviations, and CAPAs for manufacturing operations.
• Utilize investigation tools (e.g., 5 Whys, 6M methods) for critical or major investigations.
• Attend daily meetings with process teams to identify and address documentation needs.
• Collaborate with QA to ensure timely closure of QMS-related tasks.
• Author and revise batch records, SOPs, and forms required for manufacturing processes.
• Manage and submit GMP-related documents to QA.
• Support critical production campaigns, including occasional wet lab work (~10%).
• Ensure compliance with company policies and regulatory standards.
• Perform additional duties as required.

Qualifications:

Education & Experience:

• Bachelor’s degree in Biological Sciences or a related technical field.
• At least 5 years of experience in the biopharmaceutical industry.
• Strong knowledge of upstream and downstream processes in biologics manufacturing.

Skills & Competencies:

• Excellent interpersonal and communication skills, both verbal and written.
• Proficiency in tools such as Microsoft Word and Excel.
• Highly organized with attention to detail.
• Knowledge of GMP batch manufacturing, packaging documentation, and audits.
• Experience with cleaning verification and validation.

This position is ideal for individuals with a solid background in QMS processes, a strong attention to detail, and a passion for contributing to advancements in biopharmaceutical manufacturing.