**Manufacturing QMS Associate** Regulatory Affairs Chicago, IL, US Pay Rate Low: 70.000 | Pay Rate High: 85,000 + Added - 16/01/2025 Apply for Job _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:** + Strong interpersonal skills and the ability to work both independently and as part of a team. + Excellent verbal and written communication skills. + Good computer skills, including proficiency in Word, Excel, and spreadsheets. + Highly organized and detail-oriented. + Familiarity with GMP batch manufacturing and packaging documentation, including auditing and review. + Knowledgeable in cleaning verification and validation processes. INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.