Pciservices · Bedford, NHPrepare for this interview
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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. JOB DESCRIPTION: Position Title : QA Operations Specialist I - Floor Support Location: Bedford, New Hampshire Department: Quality Assurance, Reporting To: QA Supervisor, Responsible For (Staff): No The QA Operations Specialist I - Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial medical device products in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and fill processes, GMP documentation and Batch Record review, line clearance, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of Medical device products. ESSENTIAL DUTIES AND RESPONSIBILITIES: Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time. Perform periodic walkthroughs of manufacturing and support areas to ensure adherence to policies and procedures. Batch record review for adherence to internal procedures and Good Documentation Practices Review, approval and disposition of incoming materials such as consumables, excipients, and bulk device Ingredient, as applicable. QA review and approval of new and revised GMP documents such as SOP's and raw material specifications. Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions. Assist in nonconforming material investigations. Review of Quality Control Environmental Data Review and approval of work orders impacting manufacturing facilities and utilities May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc. Advise and coach internal customers on proper documentation of tasks Assist in the initiation of Quality Systems (deviations, CAPA, Nonconformances). Support Visual Inspection, packaging, and labeling operations Create, review, and approve final product labels 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 directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices
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