Description:

The Manager, Quality Control (QC) – Operations supports the Quality Control laboratories, maintaining a state of GMP compliance and efficient operation with regard to equipment and lab reagents . The Manager, QC – Operations is responsible for maintaining the calibration and preventative maintenance schedule for existing equipment, and inventory and ordering for QC lab supplies.

Duties and Responsibilities:

• Interface with QC Analytical, QC Microbiology, Facilities, Validation, Supply Chain and Quality Assurance to clearly communicate the activities and needs of the QC teams regarding laboratory operations.

• Maintain accurate and timely GMP documentation for all equipment, including equipment logbooks, preventative maintenance forms, calibration certifications, out-of-service tags, etc.

• Schedule and complete preventative maintenance (PM) activities for laboratory equipment, including fridge/freezers, incubators, and analytical equipment.

• Coordinate with equipment vendors on service contracts, including scheduling field representatives for on-site PM and calibration activities.

• Schedule and oversee the on-site and off-site calibration work, subcontracted to a vendor, for micro-pipets, centrifuges, biosafety cabinets, and applicable equipment.

• Support the purchase of new equipment, by coordinating with Finance and Supply Chain on reviewing quotes, Purchase Orders, and installation plans.

• Author and review Standard Operating Procedures (SOPs) for equipment and software, and revise in response to Corrective Actions / Preventative Actions (CAPAs).

• Support Validation in the design and execution of Installation Operation Qualification, Performance Qualification, and Software Validation activities, as required.

• Open and close Change Control records to document the movement and re-validation of equipment, in coordination with other departments.

• Serve as primary responder to alarm notifications from the Environmental Monitoring System (EMS), regarding temperature, humidity and CO2 levels for the laboratories and equipment. Open Quality Events for these occurrences (if applicable).

• Establish and maintain procedures for inventory and ordering of consumable materials in the QC laboratories, for Raw Materials under formal specifications as well as for non-specification materials. Coordinate with Supply Chain on establishing order quantities and re-order levels for materials.

• Maintain the inventory of Drug Substance and Drug Product retains.

• Work within Abeona’s Quality System to document deviations and drive process improvements: author quality events, laboratory investigations, change controls, and corrective action / preventative action (CAPA) plans.

• Adhere to Good Documentation Practices (GDocP) and Good Manufacturing Practices.

  Qualifications: 

• Bachelor's degree in science and 5-8 years relevant experience in a CRO / CDMO / biotechnology company / pharmaceutical company, including 1 – 4 years leading one or more direct reports.

• Experience working in a regulated (GLP, GMP) environment.

• Experience conducting laboratory testing, including knowledge of cell and molecular biology equipment and techniques.

• Experience coordinating with outside vendors and across departments.

• Maintain a Growth Mindset: receive constructive feedback from peers and manager; be vocal in sharing constructive feedback with the team and manager.

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