Quality Assurance Associate

Work Schedule: 12-hour Continental Shifts (Days and Nights- 7:00 AM – 7:00 PM or 7:00 PM – 7:00 AM)

This position is 100% on-site in Strathroy, Ontario.

Performs in-process document auditing and product quality checks in production and ensures all issues are communicated to production employees, production management and QA management.

Performs Final Release auditing of batch documentation ensures all product has been manufactured in compliance with cGMP’s and SOP’s. This includes performing all duties required to release the final product.

Assists in the investigation of manufacturing issues and manufacturing deviations as reported by the production departments.

Performs in-process product quality checks and documentation review.

Performs weekly compliance audits/monitoring in all production and packaging departments and prepares result reports for QA management.

Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and QA management as required.

Performs line clearance verifications of equipment and processing areas during changeovers from one type of product to another type of product – may include testing/verification of vision equipment.

Perform other duties as assigned.

Bachelor’s degree in science, Engineering (Chem., Bio Chem.) or related field is required.

Prior experience in a manufacturing, pharmaceutical and/or GMP facility would be an asset.

Strong analytical and problem-solving skills.

Extremely detailed oriented. Excellent prioritization and time management skills.

Strong interpersonal skills. Excellent communication skills – verbal and written.

Able to work independently with minimal supervision.

Advanced computer skills in MS Excel and Word.

Candidates with non-Canadian credentials must provide an evaluation confirming the Canadian equivalency of the credentials as determined by the Alliance of Credential Evaluation Services of Canada (ACESC) such as WES.

This position does not qualify for sponsorship.

The employee's role frequently involves sitting and utilizing hands and fingers for tasks such as handling, feeling, and keyboard manipulation, necessitating manual dexterity.

Occasionally, the position requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, alongside close vision capabilities and potential exposure to chemicals.

Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)

Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions.

Employee Reward & Recognition programs.

Opportunities for professional and personal development & growth including tuition reimbursement.