AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
We are seeking a Quality Assurance Manager to support AbCellera's GMP/GDP Warehouse and Logistics/Supply Chain operations. This position will provide Quality oversight of our Warehousing and Logistics operations, including the receipt/shipment of incoming materials and samples, Drug Substance (DS), Bulk Drug Product (DP), and finished Drug Products Products (FDP) to support AbCellera's cGMP Clinical Manufacturing facility.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
We’d love to hear from you if
- You are someone who is enthusiastic about adopting innovative approaches that enable agile, sustainable compliance.
- You have experience leading, overseeing, participating, and executing activities for Warehouse & Logistics operations
- You are comfortable and work well within cross-functional teams providing QA oversight and support in an evolving, complex, and dynamic environment
How you might spend your days
- Developing and/or supporting the development of all departmental processes and procedures for QA oversight of Warehouse and Logistics operations.
- Ensuring accuracy and maintenance of departmental procedures, reviewing temperature mapping studies and routine temperature monitoring of the warehouse
- Reviewing qualification and validation of inventory control systems, and maintaining applicable material management systems.
- Reviewing and verifying shipping and receiving documentation
- Overseeing investigations related to Warehouse and logistic operations and ensuring corrective and preventive actions are implemented to eliminate investigations due to failures or errors.
- Reviewing commissioning and qualification of the warehouse areas, including ongoing review and approval of monitoring and alarm data needed to demonstrate environmental controls.
- Providing QA oversight of QC Raw Material sampling, Material Weigh/Dispense and/or Warehouse ‘Pick’ operations for fulfillment of Production Orders (BOMs) and/or Material/Product shipments.
- Ensuring the appropriate status, segregation and control of materials stored within the warehouse area.
Requirements and Qualifications
- Bachelor's Degree in an applicable science and a minimum of 6 years of relevant QA experience.
- Strong knowledge of QA operations, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Distribution Practices
- Strong understanding of data integrity requirements and cGMP, USP, ICH, EP and FDA guidelines.
- Excellent communication skills and be able to provide accurate and timely reporting of Quality metrics to QA and Logistics management