Manager, Quality Control
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Key skills for this role
Role Overview
Lead quality control operations for sterile ophthalmic products at the Arnprior facility.
Ensure GMP compliance for materials, products, processes, testing, and release activities.
Manage QC operations, stability programs, investigations, documentation, audits, and cross-functional coordination.
Key Skills for This Role
Full Job Posting
Role overview
Lead quality control operations for sterile ophthalmic products at the Arnprior facility.
Ensure GMP compliance for materials, products, processes, testing, and release activities.
Manage QC operations, stability programs, investigations, documentation, audits, and cross-functional coordination.
Key responsibilities
- Lead and supervise the QC department, including training and performance evaluations.
- Oversee stability testing, shelf-life protocols, software setup, and analyst coordination.
- Manage analytical investigations and closure of CAPAs, change controls, and deviations.
- Support new product introductions and product transfers with analytical testing and GMP alignment.
- Approve specifications, APRs, GMP documentation, LIMS updates, and customer agreements.
- Coordinate testing schedules and balance manufacturing priorities with QC resources.
- Oversee instrument qualifications and vendor service and maintenance relationships.
Qualifications and requirements
- University degree or college diploma in a relevant scientific discipline; chemistry is preferred.
- At least 10 years of pharmaceutical manufacturing experience and drug formulation expertise.
- Particular experience with ophthalmic formulations is required.
- At least 2 years of supervisory leadership experience with direct reports.
- Experience with analytical testing support, product transfers, and GMP compliance.
- Experience with analytical investigations and closure of CAPAs, change controls, and deviations.
- Excellent communication, interpersonal, and customer service skills.
Salary
- The salary range is $91,000 to $102,000 per year.
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