Development QA Specialist - Contract

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.

Position Summary

Reporting to the Development Quality Assurance Manager, the Development QA Specialist will provide QA batch auditing, specification and other documentation review and approval support for Catalent Ontario Development projects.

The Role

• Review and sign off on manufacturing and packaging master batch records for product development batches ensuring accuracy and maintaining consistency.

• Perform auditing of the executed manufacturing and packaging product development batch records ensuring all issues are communicated to Production, Formulations and QA management as required.

• Review and approve development related Reprocessing documents, Approved Temporary Specifications, change controls, specifications, deviations, and laboratory investigations as required.

• Assist in the investigation of manufacturing and packaging issues deviations occurred during the processing of product development batches, including CAPA implementation.

•  Ensure outstanding corrective actions assigned to R&D are completed on time.

• Responsible for the filing and archiving of the product development batch records, Strathroy site bulk and packaging PDS QA retains, and product soft gel specifications.

• Prepare monthly reports with regards to Ephedrine and Halal gelatin production activities ensuring they are submitted on time.

• Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.

The Candidate

• Diploma or bachelor’s degree in science or related field.

• 1+ years’ experience in Quality Assurance or related field.

• Experience working in a manufacturing, pharmaceutical and or GMP facility.

• Effective in communicating with all types and levels of staff, including technical, professional, and upper management.

• Advanced computer skills in a varied of computer-based applications.

• Extremely detail oriented.

• Ability to work independently with minimal supervision.

• Strong problem solving, analytical, and interpersonal skills.

• Exceptional interpersonal skills with the ability to build strong relationships.

• Excellent time management and task execution skills.

Working Conditions

• Regular working hours: 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch

• 14-month contract

• 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.

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. 

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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.