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Quality Assurance Associate
Catalent is looking for a Quality Assurance Associate to join their team
The Quality Assurance Associate creates a culture of quality compliance and continuous improvement, which meets the government, customer and business requirements. The focus is on prevention rather than detection of quality issues.
Strathroy, Ontario is one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full service turnkey solutions.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
- 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 ensure 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 which includes completing quality checks as required.
- Performs compliance audits in all production departments and prepares result reports for product and 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.
- Other Duties as assigned.
Work schedule: 12 hour rotating continental shifts as defined by rotation schedule.Education RequirementPost Secondary Degree Experience Requirement
- Bachelor’s Degree in Science, Engineering (Chem., BioChem.) or related field
- Prior experience in a manufacturing, pharmaceutical and/or GMP facility would be an asset.
- Prior laboratory experience would be an asset.
- While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required. The employee is occasionally required to stand, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. There is also the potential exposure to chemicals
- Comprehensive BenefitPackage (Health, Dental, Vision, & Life Insurance)
- Group Retirement Savings – Registered Pension Plan (RPP) with employer contributions
- Paid Time Off Programs incl. vacation, banked time & personal time
- Employee Reward & Recognition programs
- Opportunities for professional and personal development & growth incl. tuition reimbursement
Interested applicants, please click here to apply online
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.About Employer
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.