Quality Management System Specialist

by Catalent Pharma Solutions

Position Type: Full-time
Location: Strathroy, ON
Date Posted: Jul 04, 2024
Catalent Pharma Solutions

Job Description

Quality Management System Specialist


Position Summary  

The Quality Management System (QMS) Specialist is responsible for fostering a continually improving quality culture at the Strathroy Adair site. The QMS Specialist is responsible for ensuring compliance, effectiveness, and operational excellence. 


This is an exciting opportunity to play a pivotal role in developing the strategy for our new pharmaceutical site and shape the future of our operations in North America.   


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


The Role 

  • Support the quality improvement activities across site by supporting project groups to execute necessary projects. 

  • Support the development of a quality improvement culture. 

  • Develop the Quality Management System towards optimum efficiency. 

  • Support the implementation of new system and ways of working. 

  • Support the development and execution of strategies to strengthen the Quality culture within other site functions. 

  • Challenge constraints on operational activities to remove illogical activities and non-value adding process steps. 

  • Lead joint initiates with customers to improve operational quality performance. 

  • Review Approve and Close QMS systems records.

  • Perform other duties as required. 


The Candidate 

  • Bachelor's Degree in Life Sciences or related field. 

  • Minimum 2 years of experience in Quality, Operations, or related field. 

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

  • Proven track record of operating in a complex regulated manufacturing environment.

  • Understanding of the overall business needs and objectives.

  • Expertise in contemporary tools to meet current and advancing cGMP requirements.? 

  • Direct experience of preparation, involvement relating to FDA and HPFBI inspections. 

  • Ability to sit and use hands and fingers, to handle or feel and to manipulate keys on a keyboard.  

  • Use of manual dexterity is required.

  • Ability 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 


Why You Should Join Catalent  

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

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

  • Paid Time Off Programs including vacation, banked time & personal time 

  • Employee Reward & Recognition programs 

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


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.