Job Title: QA Manufacturing Associate

Work Location: Westchester County, New York

Summary:

Seeking a QA Manufacturing Associate to provide quality assurance oversight and support for manufacturing operations, ensuring compliance with GMP standards and regulatory requirements.

Responsibilities:

• Conduct real-time quality assurance activities on the manufacturing floor, including room release, process observation, and immediate issue resolution.
• Perform visual inspection of drug products using Acceptable Quality Limit (AQL) standards.
• Review and approve batch documentation for media and buffer preparation solutions.
• Create, update, and maintain GMP documentation such as SOPs, Master Batch Records, and related materials.
• Document and manage deviations observed during manufacturing, ensuring timely completion and resolution.
• Provide quality oversight for GMP operations, including the manufacture of cell banks, bulk drug substances, and final drug products, with significant time spent on the production floor.
• Audit manufacturing and support areas, including in-process batch record review, to ensure adherence to procedures and Good Documentation Practices.
• Drive and participate in continuous improvement initiatives related to quality and process optimization.

Qualifications:

• High School Diploma required; Bachelor’s degree in STEM sciences preferred, or equivalent experience.
• Minimum of 2 years’ experience in the biologic, biopharmaceutical, or regulated industry.
• Experience in Manufacturing, Quality Assurance, or Quality Control functions preferred.
• Strong understanding of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations (21 CFR Parts 600s), ICH Guidelines, and EU GMPs.
• Familiarity or experience with biological manufacturing processes, including microbial and cell culture banking, fermentation/cell culture, purification, and fill/finish operations.

Published Category: Manufacturing & Technical Operations