Quality Assurance Associate

Quality Assurance Associate About Site 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. 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 will be on preventing quality issues rather than detecting them. You will also coach and train operators and supervisors on proper documentation practices and current Good Manufacturing Practice (cGMP) requirements. Shift: 12 hour rotating continental shifts (Days and Nights) Location: Windsor, ON 100% Onsite The Role Perform in-process batch review of documentation to ensure compliance with cGMPs and Standard Operating Procedures (SOPs), including coaching and training employees and supervisors on each issue. Assist in initiating manufacturing events and deviations as reported by production departments, ensuring product with potential quality issues is acceptable for release and reports are updated. Perform line clearance verifications of equipment and processing areas during product changeovers, which may include testing and verification of vision equipment. Act as Quality Assurance representative on shift for decision-making and issue resolution, escalating serious issues to production and QA management as required. Issue, review, and file various logs from operational areas, including equipment logs and temperature/relative humidity logs. Monitor GMP compliance in operating areas to maintain inspection readiness. Participate in special projects in other areas of quality and compliance, and work extended hours or weekends as needed to meet deadlines or resolve issues. Perform other duties as required. The Candidate Minimum Requirements Bachelor’s degree in science (Chemistry or Biochemistry preferred) is required. Experience working in a manufacturing, pharmaceutical, and/or GMP facility is an asset. This position does not qualify for sponsorship. 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 World Education Services (WES). The role frequently involves sitting and using hands and fingers for tasks such as handling, feeling, and keyboard manipulation, requiring manual dexterity. Occasionally, it requires standing, walking, reaching, bending, twisting, stooping, kneeling, crouching, or crawling, along with close vision capabilities and potential exposure to chemicals. Preferred Skills & Background Advanced computer skills in Microsoft Office Suite (Outlook, Excel, Access, Word). Strong analytical and interpersonal skills. Extremely detail-oriented. Excellent verbal and written communication skills. Able to work independently with minimal supervision. Pay The final salary offered to a successful candidate may vary within this range $48,000 – $57,000, 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 [email protected]. 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.

The Quality Assurance Associate performs in-process batch reviews and ensures compliance with cGMPs and Standard Operating Procedures. They also act as a quality representative on shift to resolve issues and provide coaching to production staff.

A Bachelor's degree in science, specifically Chemistry or Biochemistry, is required for this role. Candidates should have experience in a manufacturing, pharmaceutical, or GMP facility and possess strong analytical and communication skills.

• Health insurance • Dental insurance • Vision insurance • Life insurance • Group retirement savings • Registered pension plan • Employee reward and recognition programs • Tuition reimbursement

• Assurance qualitéSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Quality assurance
• cGMP compliance
• Documentation review
• Batch review
• Standard operating procedures
• Line clearance
• Analytical skills
• Interpersonal skills
• Detail-oriented
• Communication skills
• Microsoft office suite
• Coaching
• Training
• Issue resolution
• Inspection readiness
• Current Good Manufacturing Practices (cGMPS)
• Equipment Logs
• Ability To Meet Deadlines
• Microsoft Access
• Microsoft Excel
• Chemistry
• Biochemistry
• Management
• Business Requirements
• Good Manufacturing Practices
• Decision Making
• Clinical Trials
• Communication
• Computer Literacy
• Continuous Improvement Process
• Drug Development
• Packaging And Labeling
• Standard Operating Procedure
• Leadership
• Interpersonal Communications
• Problem Solving
• Fine Motor Skills
• Microsoft Outlook
• Microsoft Office
• Pharmaceuticals
• Quality Assurance
• Safety Assurance
• Train Operation
• Detail Oriented

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

Formation minimale

Baccalauréat

Expérience minimale

0+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine