Quality Assurance Associate

Catalent; Adelaide Metcalfe; On-site; CAD 48,000 - 59,000; Full time

Job summary

A global pharmaceutical company is seeking a Quality Assurance Associate in Ontario responsible for ensuring quality compliance and performing product audits. The ideal candidate will have a Bachelor's degree in science and possess strong analytical, problem-solving, and communication skills. This role requires attention to detail and the ability to work independently. Offering a salary range of $48,000.00 – $59,000 depending on experience. Join a leader in drug development and make a difference.

Benefits

Comprehensive Benefit Package

Group Retirement Savings

Employee Reward & Recognition programs

Tuition reimbursement opportunities

Qualifications

• Bachelor’s degree in science, Engineering (Chem., BioChem.) or related field is required.
• Prior experience in a manufacturing, pharmaceutical and/or GMP facility would be an asset.
• Advanced computer skills in MS Excel and Word.

Responsibilities

• Perform in-process document auditing and product quality checks.
• Perform Final Release auditing of batch documentation.
• Assist in the investigation of manufacturing issues.

Skills

Analytical skills

Problem-solving skills

Attention to detail

Time management skills

Interpersonal skills

Communication skills

Independent working

Advanced Excel skills

Advanced Word skills

Education

Bachelor’s degree in science or Engineering

Job description

Quality Assurance Associate

Position Summary

• Work Schedule: 12-hour Continental Shifts (Days and Nights- 7:00 AM – 7:00 PM or 7:00 PM – 7:00 AM)
• This position is 100% on-site in Strathroy, Ontario.

This position is located in Strathroy, 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, the Quality Assurance Associate creates a culture of quality compliance and continuous improvement, which meets the government, customer and business requirements. The focus is on prevention rather than detection of quality issues. In addition, the Quality Assurance Associate will perform final product audit for product release and coaching and training operators and supervisors on proper documentation practices and cGMP requirements.

The Role

• Performs in-process document auditing and product quality checks in production and ensures all issues are communicated to production employees, production management and QA management.
• Performs Final Release auditing of batch documentation ensures all product has been manufactured in compliance with cGMP’s and SOP’s. This includes performing all duties required to release the final product.
• Assists in the investigation of manufacturing issues and manufacturing deviations as reported by the production departments.
• Performs in-process product quality checks and documentation review.
• Performs weekly compliance audits/monitoring in all production and packaging departments and prepares result reports for QA management.
• Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and QA management as required.
• 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.
• Perform other duties as assigned.

The Candidate

• Bachelor’s degree in science, Engineering (Chem., BioChem.) or related field is required.
• Prior experience in a manufacturing, pharmaceutical and/or GMP facility would be an asset.
• Strong analytical and problem-solving skills.
• Extremely detailed oriented. Excellent prioritization and time management skills.
• Strong interpersonal skills. Excellent communication skills – verbal and written.
• Able to work independently with minimal supervision.
• Advanced computer skills in MS Excel and Word.
• 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.
• This position does not qualify for sponsorship.
• 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.

Pay

The final salary offered to a successful candidate may vary within this range $48,000.00 – $59,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and this salary range does not reflect positions that work in other countries.

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 to 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.