Quality Engineer III Position Available In St. Louis City, Missouri

Job Title:

Quality Engineer III Job Description We are seeking a Quality Engineer III who is a quality assurance professional with substantial prior experience in a Quality or Manufacturing organization within a highly regulated industry. The role involves evaluating production processes and performance in manufacturing, and participating in projects to engineer quality improvements of existing production processes as well as the development of new processes to improve quality and efficiency. Responsibilities Oversee activities and provide QA-related input. Collaborate with cross-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality. Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations in preparation for internal quality audits, client audits, and regulatory inspections. Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination. Participate in client and regulatory audits as a subject matter expert on Fit and Finish, Changeover, and Change Control procedures and practices. Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices. Perform daily GEMBAs of manufacturing areas and provide immediate feedback to colleagues and area management to ensure compliance with cGMPs, site procedures, and regulatory requirements. Perform QA approval of suite and equipment changeover between client processes. Perform autoclave logbook review and facilitate corrections. Conduct Fit and Finish inspections per the risk assessment and guiding procedures. Perform monthly aseptic observations of critical activities performed in Biosafety Cabinets. Attend and actively participate in QA OTF Tier 1 huddles. Act as Quality Management Representative as needed. Develop one’s own knowledge and skills. Provide training, coaching, and mentorship to new and/or less experienced team members on quality standards and effective strategies. Qualify new team members to perform tasks that require QSME training. Write and review deviations in Trackwise as required. Author, revise, and review procedures in eDMS as required. Write and implement CAPAs as needed. Conduct or participate in investigation interviews/RAPIDs as required. Utilize tact and diplomacy with internal and external customers to resolve issues and maintain quality culture and standards. Essential Skills Experience in quality assurance, inspection, and GMP. Proficiency in audit and quality inspection. GMP/FDA Pharmaceutical QA Experience. On-floor QA oversight over processes. Experience with CAPAs and SOPs/batch record review. Leadership experience or independent decision-making. Root cause analysis and batch record review. Proficiency in smartsheet. Additional Skills & Qualifications Bachelor’s Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry) or another science-related field combined with a minimum of five years of relevant experience. Cleanroom manufacturing experience highly preferred. Comfort level with full ISO 5 and ISO 7 gowning requirements. Non-science degrees considered with a minimum of seven years of directly related work experience in biopharmaceutical manufacturing. Understanding ‘why’ and not just the ‘how’ of processes and practices. Knowledge of Quality practices and cGMP regulations and other international health authority guidelines. Experience with investigational writing software systems like Track Wise. Technical writing skills and the ability to write/revise procedures in document management software. Tech transfer experience is a plus. Experience with Lean Manufacturing and Six Sigma methodologies. Excellent problem-solving and analytical skills. Work Environment The work environment is a fast-paced biologic drug substance manufacturing facility operating around the clock. The role involves spending 80% of the time on the floor observing manufacturing processes, ensuring adherence to SOPs and batch records, and 20% of the time at a desk reviewing quality documents and working through deviations. The facility is focused on cell process development to support clinical and commercial manufacturing. The position requires wearing a full gowning suit, including bodysuit, gloves, hair and beard nets, face covers, and safety glasses. Employees must be able to meet clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves. The ability to lift a minimum of 25 lbs independently and stand for 80% of the shift is required. The role involves working night shifts from 6:15 pm to 6:45 am on a rotating 12-hour shift schedule (2-2-3 schedule).