Quality Assurance Associate

7 days ago

Strathroy, Canada Catalent Full time

**Quality Assurance Associate**

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**

Reporting to the Quality Assurance Supervisor (Operations), the Quality Assurance Associate (Operations) will create a culture of quality, compliance, and continuous improvement, which meets the government, customer, and business requirements. The incumbent's focus will be on prevention rather than detection of quality issues. In addition, the role includes coaching/training operators and supervisors on proper documentation practices on cGMP requirements.

**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
- Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
- Bachelor's Degree in Science, Engineering (Chem., BioChem.) or related field
- 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
- Extremely detailed oriented
- Strong interpersonal skills
- Excellent communication skills — verbal and written
- Able to work independently with mínimal supervision.
- The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard.
- Use of manual dexterity is required.
- The employee is occasionally required 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.
- There is also the potential exposure to chemicals.

**Shifts**: 12-hour Continental Shifts

**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 incl. vacation, banked time & personal time;
- Employee Reward & Recognition programs;
- Opportunities for professional and personal development & growth incl. 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.

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