Quality Assurance Associate

Catalent Pharma Solutions; Windsor; On-site; CAD 50,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Quality Assurance Associate, where your expertise will ensure compliance and quality in pharmaceutical manufacturing. This role emphasizes prevention over detection, fostering a culture of continuous improvement. You will be pivotal in coaching and training staff on proper documentation practices while working in a dynamic environment. With a commitment to patient safety and product excellence, this opportunity offers a rewarding career path in a company dedicated to making a difference in the health and wellness of individuals globally.

Benefits

Comprehensive Benefit Package

Group Retirement Savings

Employee Reward & Recognition programs

Tuition reimbursement opportunities

Qualifications

• Bachelor's degree in Chemistry or Biochemistry preferred.
• Experience in a manufacturing or GMP facility is an asset.

Responsibilities

• Perform in-process batch review of documentation.
• Assist in initiation of manufacturing events and deviations.
• Monitor GMP compliance in operating areas.

Skills

Analytical Skills

Interpersonal Skills

Attention to Detail

Communication Skills

Microsoft Office Suite

Education

Bachelor’s degree in Science

Job description

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 totheQuality Assurance Supervisor (Operations), theQuality 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 focuswillbeon preventionrather than detection of quality issues.In addition, the role includes coaching/training operators and supervisors on proper documentationpractices 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 Alliance of Credential Evaluation Services of Canada (ACESC) such as WES.

• The employee's role frequently involves sitting and utilizing hands and fingers for tasks such as handling, feeling, and keyboard manipulation, necessitating manual dexterity.

• Occasionally, the position requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, alongside close vision capabilities and potential exposure to chemicals.

Why You Should Join Catalent:

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

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

• 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.

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 [e-mail]. 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.