Job Description

0077870 Quality Assurance Supervisor

Position Summary:

Reporting to the Manager, QA Operations, the Quality Assurance Supervisor (Operations and Documentation Auditing) is accountable for assigning the day-to-day priorities of the Quality Assurance Associates (salary staff) and the Quality Assurance Documentation Auditing Group (hourly 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 Windsor site specific customer complaint investigations.

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.

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

The Role:

Duties and Responsibilities

Communicates the daily work plan, problems/issues that arise as well as accomplishments achieved to Quality Assurance management, the operations team and 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.

Supervision, planning and implementation of all quality activities to optimize production and batch release within safety, legislative, environmental and company requirements. This includes training and qualifying Quality Auditors and assuring consistency of auditing and reviewing the monthly schedule from Production Planning to determine the required headcount for Document Auditing, flexing where required.

Acts on behalf of the Manager, QA Operations in meetings and workshops to ensure representation of QA values and ideals in all current initiatives and decision-making processes and assign disposition to finished product in reference to written quality criteria and assists QA Management in continuous improvement activities.

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. And provides leadership, motivation, and training and development for employees while Monitoring/correcting performance of employees in accordance with company policies and procedures.

Reviews and approves: Approved Temporary Specifications, requests for reprocessing, non-conformance reports, change controls, customer complaints, General Requests for Analysis, validation/qualification protocols and reports, ensures all manufacturing batch documents related to finished products produced at the site are properly maintained and controlled and participates in special projects as required in other areas of quality and compliance.

Participates in and drives the implementation of continuous improvement initiatives in the Quality Assurance area.

Liaison with customer QA contacts regarding Quality issues and items referenced on Quality Agreements. Participates in in the Customer Complaints System and conducts investigation/forwards to technical experts as required.

Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met. Must be available as an on-call resource when issues requiring direction are experienced during off business hours (weekends/nights) and performs other duties as required.

The Candidate:

Bachelor\xe2\x80\x99s degree in science, Engineering (Chem., BioChem.) or related field is required.

Minimum 3+ years of experience in QA/QC or related field.

Experience working in a manufacturing, pharmaceutical and/or GMP facility is an asset.

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.

Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and HPFBI inspections.

Ability to multi-task and prioritize.

Ability to respond quickly and to a changing regulatory environment.

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.

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 including Vacation, banked time, and personal time.

Employee Reward and Recognition Programs.

Opportunities for professional and personal development.

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\xe2\x80\x99s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

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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 . 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.

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