Main Tasks and Responsibilities Provide QA floor support and oversight to the production of registration batches for clinical and commercial product materials to ensure that product is manufactured in accordance with specifications, customer’s market authorizations and GMP requirements. Conducts floor audits and periodic checks of in process documentation and logbooks for compliance during second shift.Provide guidance to manufacturing and laboratory personnel to proactively ensure GMP compliance.Ensures timely initiation of deviations when quality issues are identified. Perform room and equipment releases and line clearance activities in support of on-time manufacturing.Review and release raw materials and components for dispensing to be used in manufacturing.Review and approval of the executed cleaning validation/verification reports. Review and issue product labels for use in manufacturing. Participate in investigations related to deviations, out-of-specifications or atypical results, and customer complaints. Identify and implement corrective and preventive actions that mitigate potential for issue recurrence. Communicate quality-related information and data to key stakeholders within and outside of QA. Engage on manufacturing meetings and assure appropriate assignments of quality activities.Perform other duties as assigned, and may need to adjust the timing based on the manufacturing schedule.Physical DemandsWhile performing the duties of this job, the employee is frequently required to stand and walkThe employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl.The employee must occasionally lift and/or move up to 10 pounds.Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.Must be able to qualify for respiratory protective equipment use. The CandidateAssociate degree in a scientific field, or equivalent experienceMinimum three (3) years’ related experience in QA or QC in life sciencesGood understanding of CGMP requirementsGood organization and time management skillsEffective written and oral communication skillsGood interpersonal skills with a special focus on customer satisfaction