Qa Associate I Ops

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. SECOND SHIFT Position Title: QA Associate I - Operations Location: Madison, Wisconsin Department: Quality Assurance Reporting To: Quality Assurance Operations Supervisor Responsible For (Staff): No The Quality Associate I - Operations is the first of two levels within the QA Associate jobfamily Theassociate I provides real-time QA support on the floor for GMP Manufacturing of drug product. The work scope includes floor oversight of manufacturing includingobservingcritical processes and performing AQL visual inspection,executedGMP documentation review and supporting other QA functions as needed.Real timecontinuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phaseappropriate GMPmanufacture of drug products ESSENTIAL DUTIES AND RESPONSIBILITIES: Perform QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Review executed Manufacturing Batch Records and supporting documentation for completeness,accuracyand compliance Support the evaluation and lot disposition of intermediates, finish bulk drugsubstanceand drug product Act as first responder for on the floor quality issuesin a timely manner, documentation of all events/investigations andrequiredimmediate corrective actions Mayparticipatein root cause analysis using methodologies,such as:fishbone, 5 whys, etc. Act as QA reviewer for deviations and CAPA issuance; with limited approval authority asdesignatedby QA Management Perform Acceptable Quality Limit (AQL) visual inspection of drug product Participate in SOP revision as it pertains to process improvements Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary Guide personnel indirectly and... 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/2A2CFCEB6F0D4EDE