Quality Assurance Supervisor

5 days ago

Strathroy, Canada Catalent Full time

**Quality Assurance Supervisor**

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 Senior Manager, QA Operations, the Quality Assurance Supervisor is accountable for assigning the day-to-day priorities of the Quality Assurance Associates, Senior Quality Assurance Associates and the Quality Assurance Specialist (salary staff). The incumbent is also accountable for the quality assurance and cGMP compliance activities for the manufacturing site as they relate to the entire production process and batch release. In addition, the incumbent is responsible for maintaining the archiving program of completed batch records and retention samples.

**The Role**
- Communicates the daily work plan and priorities with the Quality team to ensure delivery timelines and expectations are met or exceeded for product releases.
- Problem solves with functional areas/departments on Quality issues to assure SISPQ of the product in accordance with cGMPs, SOPs and any applicable standards.
- Support the Senior Quality Team in meetings to ensure representation of QA values and ideals in all current initiatives and decision-making processes, including and not limited to the disposition of the finished product in reference to written quality criteria.
- Works closely with the operations team to ensure that the quality management system and quality plan supports current quality management strategic themes, corporate objectives and industry requirements. Provide guidance to shop floor on cGMP, SOPs and any applicable standards on execution of production and packaging activities to assure the SISPQ of the product.
- Leads, coordinates and participates in investigations and corrective action identification and implementation process for Deviations and Right First-Time documentation. Ensures on-time closure of deviations and corrective action/preventative action items.
- Reviews and approves Quality documents which includes, but not limited to: Master Batch Production Records, Approved Temporary Specifications, Reprocessing Directives, Non-Conformance Reports, Change Controls, SOPs, and validation/qualification protocol and reports.
- Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
- Provides leadership, motivation, and training and development for employees. Monitor/correct performance of employees in accordance with company policies and procedures.
- Bachelor’s Degree in Science, Engineering (Chem., BioChem.) or related field.
- 3-5 years of experience in QA/QC or related field is preferred.
- Experience working in a manufacturing, pharmaceutical and/or GMP facilities preferred.
- Understanding of the overall business needs and objectives.
- Expertise in contemporary tools to meet current and advancing cGMP requirements.
- Excellent verbal and written communication skills.
- Ability to multi-task and prioritize.
- Ability to respond quickly and to a changing regulatory environment.

Regular working hours: 8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM with a 30-minute unpaid lunch.

**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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