Quality Assurance Associate

Quality Assurance Associate

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This position is located in Windsor, Ontario, 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.

Reporting to the Quality Assurance Supervisor (Operations), the Quality Assurance Associate (Operations) will create a culture of quality, compliance and continuous improvement, which meets the government, customer and business requirements. The Quality Assurance Associate’s focus will be on prevention rather than detection of quality issues. In addition, the role includes coaching/training operators and supervisors on proper documentation practices on cGMP requirements.

Shifts: 12-hour Continental Shifts (Days and Nights)

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.

The Role:

• Performs In-Process Batch review of documentation and ensures all product has been manufactured in compliance with cGMPs and SOPs. This includes coaching/training of employees and supervisors on each issue, ensuring that each issue has been noted and that appropriate actions are taken to address the issue.

• Assists in the initiation of all manufacturing events and deviations as reported by the production departments. Ensures that all product which has been identified as potentially having a quality issue is acceptable for release, and the reports have been updated accordingly.

• 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.

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

• Issues, reviews and files various logs from areas of operation — includes equipment log, Temp/RH logs, etc.

• Monitors GMP compliance in the operating areas to assist in maintaining inspection readiness.

• Participates in special projects as required in other areas of quality and compliance and must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.

• Performs other duties as required.

The Candidate:

• Bachelor’s degree in science (Chemistry or Biochemistry preferred) is required.

• Experience working in a manufacturing, pharmaceutical and/or GMP facility is an asset.

• Advanced computer skills in Microsoft Office Suite. (Outlook, Excel, Access, Word)

• Strong analytical skills and interpersonal skills.

• Extremely detailed oriented.

• Excellent communication skills — verbal and written.

• Able to work independently with minimal supervision.

• Currently Catalent does not participate in the Ontario Immigrant Nominee Program. (OINP).

• Candidates with non-Canadian credentials must provide an evaluation confirming the Canadian equivalency of the credentials as determined by the Alli