QA Manager

Reports To

Director of Operations

Summary

The Quality Assurance Manager will be responsible to ensure all operations are in full compliance with regulatory requirements for GMP, EUGMP, HACCP and Health Canada. The Quality Manager can execute all quality assurance and quality control tasks and will train staff to follow SOPs and GDP.

Job Duties

⦁ Establish goals and objectives for the QC / QA department for process improvement and compliance while supervising work practices for direct reports.

⦁ Implement and enforce quality management systems and risk management strategies throughout all departments by exercising mock recalls, internal department audits and facility inspections for compliance.

⦁ Prepare, maintain and update SOP library and training records to confirm adequate training is provided to all department staff and assure adherence and audit readiness of the entire facility.

⦁ Control batch / lot coding, specification compliance and tracking of in
- process product.

⦁ Monitor lots for regulatory and specification compliance, sample submission, analysis of COA testing results and perform final product approval and lot release sign off.

⦁ Review, respond, categorize and fulfill customer complaints and recalls by severity and report to appropriate authorities abiding by regulatory requirements.

⦁ Lead and advise during internal and third party audits with regulatory authorities.

⦁ Provide batch / lot fault, CAPA and customer complaint metrics to the Director of Operations for process improvement.

⦁ Evaluate calibration, equipment validation, and product specifications for compliance and improved efficiency.

⦁ Provide leadership, coaching, mentoring and training while coordinating activities of production, processing, packaging and shipping.

⦁ Participate with Director of Operations on special projects which relate to improvements in production, packaging and shipping.

⦁ Approve all production, sanitation, processing and shipping documentation after departmental review.

⦁ Review and approve daily/weekly hours of work.

⦁ Provide general management and technical guidance for QA/QC, production, processing, packaging and shipping to ensure GMP compliance.

Job Requirements

⦁ University degree in Science, Chemistry, Bioscience or equivalent.

⦁ 2-3 years previous quality assurance management experience in food, pharmaceuticals or biotechnology production required.

⦁ Security Clearance will be required for this position.

⦁ Must demonstrate effective leadership and communication skills for all levels of staff.

**Job Types**: Full-time, Permanent

**Salary**: From $70,000.00 per year

**Benefits**:

- Extended health care

Schedule:

- 8 hour shift
- Monday to Friday

Ability to commute/relocate:

- Wainfleet, ON: reliably commute or plan to relocate before starting work (required)

**Experience**:

- quality assurance: 3 years (required)
- Auditing: 2 years (required)

Work Location: One location