Quality Assurance Manufacturing Associate Position Available In St. Louis, Missouri

Quality Assurance Manufacturing Associate Responsibilities Oversee activities and provide QA-related input. Collaborate with cross-functional teams to optimize processes enhancing efficiency, productivity, and quality. Conduct thorough audits and inspections ensuring compliance with industry standards and regulations. Observe aseptic practices and coach site colleagues to prevent contamination. Participate as a subject matter expert in client and regulatory audits on Fit and Finish, Changeover, and Change Control procedures. Monitor critical process steps to ensure adherence to guiding procedures and aseptic practices. Perform GEMBA in active areas daily, providing feedback to ensure compliance with cGMP’s and site procedures. Approve suite and equipment changeovers between client processes. Review autoclave logbooks and facilitate corrections. Conduct Fit and Finish inspections per risk assessments and guiding procedures. Perform monthly aseptic observations in Biosafety Cabinets. Participate in manufacturing and QA huddles. Act as Quality Management Representative as needed. Essential Skills Proven quality assurance and inspection experience. Understanding of GMP and FDA pharmaceutical QA practices. On-floor QA oversight and process experience. Proficiency in CAPAs and SOPs. Experience in batch record review and root cause analysis. Additional Skills & Qualifications Bachelor’s Degree in Life Sciences or related field with a minimum of three years of relevant experience. Cleanroom manufacturing experience preferred. Knowledge of quality practices and cGMP regulations. Experience with Track Wise and root cause analysis tools. Technical writing skills for document management software. Tech transfer experience is advantageous. Familiarity with Lean Manufacturing and Six Sigma methodologies. Work Environment The work environment involves spending 80% of the time in the core area, gowned in either blues or whites, with the remaining 20% at the desk. The position requires adherence to clean room gowning standards, including wearing Tyvek, Nitrile, and Latex gloves. The role follows a rotating 12-hour day shift schedule (6:15am-6:45pm) with a 223 schedule, requiring the ability to lift a minimum of 25 lbs independently and stand for 80% of the shift. The facility is fast-paced and focused on biologic drug substance manufacturing, operating around the clock to support clinical and commercial manufacturing.