Responsibilities of this position include, but are not limited to, Quality Operations review and approval of materials, bill of materials, batch records and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.

Essential Duties and Responsibilities:

• Support operational compliance aspects of sterile fill-finish manufacturing of products including but not limited to material, bill of material and executed batch record review and approval.
• Partner with operations to develop manufacturing batch records to be compliant with regulatory and company requirements.
• Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
• Provide cross-functional support to MSAT and Operations in establishing process limits for manufacturing processes such as filling and packaging.
• Act as a resource for colleagues.
• Lead or participate in Quality Risk Management Processes as needed.
• Promote a safety and quality-first mindset in daily job functions.
• Consistently represent the Quality Unit as a proactive and GxP-compliant team player when working with Operations in daily job duties.
• Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Support material receipt, quality control, chain of custody, disposition, and release of materials within the Enterprise Resource Planning system.
• Maintain current knowledge of FDA requirements to keep pace with evolving requirements for manufacturing.
• Support, lead, or approve documents, change controls, investigations and CAPAs to support the Quality Management System.