Quality Assurance Associate
7 months ago
**0080374 Quality Assurance Associate**
**Position Summary**
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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.
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.
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.
**Shifts**: Continental Shifts (Days and Nights)
**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.
- Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met and performs other duties as required.
- 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
- 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.
- The employee is required to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl and occasionally bend and lift
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