Catalent Pharma Solutions Quality Assurance Associate in Windsor, Canada

Job Description

Position Summary

The Quality Assurance Associate reports to the Quality Assurance Supervisor.

Windsor, 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.

Are you looking to launch your career in the pharmaceutical manufacturing world?

The Quality Assurance Associate is a hands on role where you will focus on the prevention of quality issues. Reporting to the Quality Assurance Supervisor (Operations), the Quality Assurance Associate (Operations) will create a culture of quality, compliance and continuous improvement, to ensure the safety, reliable supply and optimal performance of our products. In addition, the Quality Assurance Supervisor includes coaching/training operators and supervisors on proper documentation practices and cGMP requirements.

The Role

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

  • Performs in-process review of documentation and ensures all product has been manufactured in compliance with cGMPs (Good manufacturing Practices) and SOPs (Standard Operating Procedures). This includes coaching/training of employees and supervisors on each issue, and ensuring that the appropriate actions are taken to address the issue.

  • Assists in the investigation of manufacturing issues and manufacturing deviations as reported by the production departments which includes completing quality checks as required

  • Performs line clearance verifications of equipment and processing areas during changeovers between varying product types.

  • Issues, reviews and files various logs from areas of operation – including equipment logs, temperature and humidity monitoring, etc.

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 MS Excel and Word, skilled in use of Microsoft Office

  • Extremely detailed oriented

Position Benefits

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

  • Group Retirement Savings – Defined 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

We will identify candidates based on the following Catalent Competencies:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin or disability. Accommodations are available for applicants with disabilities throughout the recruitment process. If you are selected for an interview and require accommodation for interviews or other meetings, please advise your Human Resources point of contact or email accessibility@catalent.com.

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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.