Quality Assurance Associate Ii
2 weeks ago
COMPANY SUMMARY:
RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent - investing in innovation every step of the way.
We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.
RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.
We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the RESILIENCE of a vital supply chain.
JOB SUMMARY:
Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We started an incredible journey and are looking for passionate leaders to join us on this important mission.
The Quality Assurance (QA) Operations, Associate II is responsible for quality oversight of operations at the RESILIENCE Mississauga facility. The main role is to provide an independent oversight of operations, inclusive of the production areas, warehouse, and Quality Control laboratories, to ensure that day-to-day GMP activities are executed in a compliant manner to meet company’s procedures and policy and Regulatory requirements.
The position is accountable to address QA activities relating to clinical and commercial manufacturing, and related issues which directly or indirectly impact product quality. It includes QA review and approval of Batch Records, Deviations, Laboratory Investigation, Environmental Monitoring Investigations, dispositions intermediates and Drug Substance, Change Control, and provides on the shop-floor presence.
The incumbent provides timely risk-based decision making and proactive support with the focus on operational excellence and continuous improvements.
This job reports to the Manager, QA Operations
MAJOR RESPONSIBILITIES:
Production Support:
- Perform record review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA.
- Provide quality oversight on project teams and any necessary support to meet required project deadlines while ensuring compliance to internal SOPs and applicable regulatory guidelines.
- Support Quality Systems programs and processes which may include but is not limited to internal and external audits, inspections and release for materials and product, process product returns and complaints.
- Perform Aseptic Filling/ Manufacturing surveillance, check or audits on operations activities
- Review & approval of all process & product related documentation (SOPs, master batch records, protocols, reports, specifications, etc.)
- Review & approval of product & process related change controls (includes Supplier Change notifications & Technical Transfers)
- Review and Approval of Annual Product Review reports
- Support the recall and product complaint management
- Review Supplier Quality Agreements
- Management of Client Quality Agreements
- Collaborate with Operations teams to assist in implementing and maintaining effective, risk based GMP processes, procedures, and documentation
- Second Shift schedule: 3:30PM - 11PM.
Investigation Support
- Review and approve investigation of deviations and associated CAPAs, Lab Investigations and Environmental Monitoring Reports by providing guidance and support to in root cause determination and reviewing the impact and criticality of the event with respect to product function, quality, effectiveness, safety, reliability, and customer satisfaction.
- Evaluate the appropriateness of the CAPA identified to address the root cause of the issue.
- Perform Quality and Compliance impact assessment of the event on products and processes.
- Review investigations for thoroughness and completeness and approve investigation reports.
- Perform trending of incidents and prepare monthly report for presentation to Senior Management during Quality Metrics/Quality Council Meetings.
Batch Review and Product Disposition
- Review and approve Master Batch Documents (Batch Production Records (BPR), Buffer/Solution forms, and other documentation associated to batch manufacturing.
- Review executed batch records (BPR, Buffer/Solution forms, and other doc
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