Job Information
LSNE - MADISON, LLC Supervisor Quality Assurance Internal in MADISON, Wisconsin
JOB REQUIREMENTS: Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Responsible for leading QA Associates, who provide QA support in the manufacturing of clinical and commercial drug products, to ensure compliance with the principles and guidelines of cGMP. The Supervisor, QA Ops assists in maintaining quality systems, management of investigations, materials management and providing QA support in real time for manufacturing, to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Facilities, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner. Essential Duties and Responsibilities: Provide QA support for cGMP manufacturing operations. Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release. Support QA scheduling activities by monitoring the production, and visual inspection schedules and projectmanagement deliverables, and reviewing factors that may impact schedules. Oversee Quality System Events (QSEs) by verifying a Quality reviewer has been assigned to the QSE andmonitor that the QSEs are being completed on time. Assist where needed. Lead Associates in providing QA on the floor oversight of manufacturing. Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances, AQL Sampling and Inspection of Final Package Lots. Supervise the employees in the Quality Assurance Department. Ensure all training is performed by employees, including aseptic gowning, facility flow and visual inspection. Maintain Quality Metrics for the company. Review of master and executed raw material records. Release raw materials, as necessary. Review of associated QC data to support facility and products, as applicable 12. Review Quality logbooks, as applicable. 13. Responsible for writing and revising Standard Operating Procedures, specifications, material control procedures, deviations, CAPA\'s, and Quality Investigations when applicable. Direct involvement in... For full info follow application link. LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company\'s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/B3E5BD4142EB49E1