Our biopharmaceutical client is seeking a Manufacturing QMS Associate to join their team! This position is responsible for analytical testing and data verification in a GMP-regulated laboratory.

Manufacturing QMS Associate

Pay DOE: 70,000-85,000

Location: Chicago, IL

Essential Duties & Responsibilities

• Support the manufacturing team with all types of documentation requirements.
• Review executed batch records, including those for Drug Products, Secondary Packaging, and the Upstream and Downstream departments.
• Manage and file change controls, deviations, and CAPAs for the manufacturing department.
• Track and ensure timely closure of QMS documents.
• Conduct investigations for critical or major issues using tools such as the 5 Whys or 6M method.
• Collaborate with cross-functional teams to ensure timely resolution of investigations and QMS action items.
• Author batch records, standard operating procedures (SOPs), and related forms or templates required for manufacturing processes.
• Request and submit all GMP-related documents to QA as needed.
• Participate in regulatory inspections and compliance activities.
• Provide support during critical manufacturing campaigns, including rotating shifts.
• Shop floor activities will comprise no more than 10% of your time.
• Perform additional duties as assigned.
• Adhere to all company policies, procedures, and standards.

Education:

• A minimum of a BA or BS in Biological Sciences or a related technical field is required.
• At least 5 years of experience in biopharmaceuticals.
• Knowledge of regulatory compliance.

Special Skills:

• Familiarity with GMP batch manufacturing and packaging documentation, including auditing and review.
• Knowledgeable in cleaning verification and validation processes.