Quality Assurance Associate

Job summary

The Quality Assurance Associate will perform in-process document auditing and product quality checks to ensure compliance with cGMP standards. They will also assist in investigating manufacturing issues and act as the QA representative on shift for decision-making and issue resolution.

Job details

About Site 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 We have an opportunity for a Quality Assurance Associate to join our team. In this role, you will help create a culture of quality compliance and continuous improvement that meets government, customer, and business requirements. The focus is on preventing quality issues rather than detecting them. You will support product release, coach and train operators on documentation practices, and ensure compliance with current Good Manufacturing Practices (cGMP). Shift: 12-hour Continental Shifts (Days and Nights- 7:00 AM – 7:00 PM or 7:00 PM – 7:00 AM) Location: Strathroy, ON 100% Onsite The Role Perform in-process document auditing and product quality checks in production and communicate issues to production employees, management, and QA management. Conduct Final Release auditing of batch documentation to ensure compliance with cGMP and Standard Operating Procedures, including all duties required for final product release. Assist in investigating manufacturing issues and deviations reported by production departments. Perform in-process product quality checks and documentation review. Carry out weekly compliance audits in production and packaging departments and prepare reports for QA management. Act as QA representative on shift for decision-making and issue resolution, escalating serious issues as needed. Perform line clearance verifications during product changeovers, including testing or verification of vision equipment. Perform other duties as assigned. The Candidate Minimum Requirements Bachelor’s Degree in Science, Engineering (Chemistry, Biochemistry) or related field required. Prior experience in a manufacturing, pharmaceutical, and/or Good Manufacturing Practice facility would be an asset. 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. Preferred Skills & Background No previous experience required. Strong analytical and problem-solving skills. Extremely detail-oriented. Excellent prioritization and time management skills. Strong interpersonal skills. Excellent verbal and written communication skills. Able to work independently with minimal supervision. Advanced computer skills in Microsoft Excel and Word. Candidates with non-Canadian credentials must provide an evaluation confirming Canadian equivalency as determined by the Alliance of Credential Evaluation Services of Canada (ACESC) such as WES. This position does not qualify for sponsorship. Pay The final salary offered to a successful candidate may vary within this range $48,000 – $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 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.

What you’ll do

The Quality Assurance Associate will perform in-process document auditing and product quality checks to ensure compliance with cGMP standards. They will also assist in investigating manufacturing issues and act as the QA representative on shift for decision-making and issue resolution.

Requirements

Candidates must hold a Bachelor’s Degree in Science, Engineering, Chemistry, or Biochemistry. While prior experience in a pharmaceutical or manufacturing environment is an asset, it is not strictly required.

Benefits

• Health insurance • Dental insurance • Vision insurance • Life insurance • Registered pension plan • Tuition reimbursement • Professional development

Listed skills

• Time management · Preferred
• written communication · Preferred
• Problem solving · Preferred
• Quality assurance · Preferred
• interpersonal skills · Preferred
• Detail-oriented · Preferred
• Microsoft Excel · Preferred
• Microsoft Word · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality assurance
• cGMP compliance
• Document auditing
• Batch documentation review
• Analytical skills
• Problem-solving
• Detail-oriented
• Time management
• Interpersonal skills
• Verbal communication
• Written communication
• Microsoft Excel
• Microsoft Word
• Line clearance
• Manufacturing processes
• Quality Assurance
• Standard Operating Procedure
• Communication
• Management
• Problem Solving
• Business Requirements
• Prioritization
• Leadership
• Decision Making
• Continuous Improvement Process
• Detail Oriented
• Pharmaceuticals
• Interpersonal Communications
• Auditing
• Safety Assurance
• Time Management
• Good Manufacturing Practices
• Report Writing
• Computer Literacy
• Product Quality (QA/QC)
• Packaging And Labeling
• Biochemistry
• Chemical Engineering
• Clinical Trials
• Fine Motor Skills
• Current Good Manufacturing Practices (cGMPS)
• Compliance Auditing
• Drug Development
• Train Operation

Job areas

• Manufacturing
• Healthcare
• Science & Research
• Engineering
• Quality Assurance Associate
• Quality Assurance Specialist
• Product Graders and Testers (except Foods and Beverages)
• Inspectors, Testers, Sorters, Samplers, and Weighers