GENERAL DESCRIPTION:
The Quality Assurance Lead provides daily operational leadership and support to the Quality Assurance department by ensuring effective execution of quality activities, maintaining GMP compliance, and supporting timely resolution of day-to-day quality matters. This role works closely with the Quality Assurance and Regulatory Manager to oversee routine quality operations, improve department efficiency, and provide quality decision-making support to Production, Packaging, and cross-functional teams.
The Quality Assurance Lead is responsible for supporting the execution of quality systems, providing oversight to QA operational activities, and driving continuous improvement initiatives.
Duties and Responsibilities
· Provide daily QA oversight and support for production and packaging operations.
· Act as the primary quality resource for routine operational quality questions and decision-making support.
· Assess and provide guidance on day-to-day quality issues, determining appropriate escalation requirements when needed.
· Support timely resolution of quality events while ensuring compliance with approved procedures, specifications, and GMP expectations.
· Perform routine area walkthroughs to ensure quality standards and GMP requirements are maintained.
Production Line Quality Oversight
· Provide leadership, guidance, and oversight to In-process Quality Technicians, ensuring consistent execution of in-process inspections, documentation review, and quality requirements.
· Review line inspection activities and documentation to ensure accuracy, completeness, and compliance with approved inspection requirements.
· Develop, revise, and formally review line inspection worksheets to ensure inspection requirements are clearly defined, risk-based, and appropriate for the product and process.
· Provide coaching and training support to In-Process Quality Technicians to improve consistency, technical knowledge, and decision-making.
· Serve as the primary Quality representative for new product line trials, providing quality oversight, supporting issue resolution, and ensuring successful product launches.
· Act as a backup In-Process Quality Technician when required due to staffing shortages or operational needs to ensure uninterrupted quality coverage.
- Support the creation, review, and implementation of packaging procedures/assembly instructions for cosmetic and OTC drug products.
- Ensure packaging procedures/assembly instructions align with approved specifications, regulatory requirements, GMP expectations, and customer requirements.
Packaging Quality Support
- Maintain and review incoming packaging inspection documents to support production activities.
- Provide quality support during packaging activities, including line start-up, inspection requirements, and troubleshooting of quality-related issues.
- Support investigations related to packaging defects, component issues, and packaging process concerns.
- When required, act as back up support for packaging inspection activities when required due to staffing shortages or operational needs.
- Support the Change Control process for packaging component and artwork revisions, ensuring updates are reviewed, implemented, and documented in accordance with GMP and customer requirements.
Supplier Quality Support
- Support supplier-related quality issues, including packaging component defects, material concerns, and supplier non-conformances.
- Assist with supplier NCR investigations, root cause assessments, corrective actions, and CAPA follow-up activities.
- Review supplier responses and supporting documentation to ensure appropriate corrective actions are implemented and effective.
- Support communication between Quality, Procurement, Technical Services, and suppliers to resolve packaging material quality concerns.
GMP Compliance & Audit Support
- Assist with GMP compliance activities, including internal inspections, customer audits, regulatory inspections and training.
- Support preparation of audit responses, corrective actions, and effectiveness checks.
- Participate in GMP walkthroughs and identify opportunities for compliance improvements.
- Promote GMP awareness and quality culture throughout production and operational teams.
Cross-Functional Support
- Act as a quality resource and point of contact for Production, Packaging, Technical Services, Supply Chain, and other cross-functional teams.
- Provide quality input during operational discussions, process improvements, and manufacturing challenges.
- Support risk assessments and quality evaluations related to changes, deviations, and process improvements.
- Identify opportunities to improve quality processes, reduce recurring issues, and enhance operational effectiveness.
Education
- Relevant post-secondary education or certifications in Quality Assurance, Regulatory Affairs, GMP, or related fields.
- Additional training in pharmaceutical, cosmetic, or OTC regulatory requirements is considered an asset.
Experience
- 5+ years of experience in Quality Assurance, Quality Control, Regulatory Affairs, compliance, or document management within cosmetic, personal care, pharmaceutical, or OTC manufacturing environments.
- Experience supporting FDA and Health Canada regulated manufacturing environments.
- Strong experience with GMP compliance, audits, inspections, deviations, investigations, CAPAs, and quality documentation.
- Experience developing, reviewing, and implementing SOPs, work instructions, packaging procedures, and inspection documentation.
Pay: From $29.00 per hour
Benefits:
- Company pension
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Vision care
Work Location: In person
