Quality Assurance Supervisor
Position Summary
Work Schedule: Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.
This position is 100% on-site in Strathroy, Ontario.
This position is located in Strathroy, 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.
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 Quality Assurance Supervisor 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.
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.
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. Ensures all manufacturing batch documents related to finished products produced at the site are properly maintained and controlled.
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.
Liaise with customer QA contacts regarding Quality issues and items referenced on Quality Agreements.
Provides leadership, motivation, and training and development for employees. Monitor/correct performance of employees in accordance with company policies and procedures.
Performs other duties as assigned.
The Candidate:
Bachelor’s degree in science, Engineering (Chem., BioChem.) or related field is required.
3+ years of experience in QA/QC or related field is preferred.
Experience working in 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 and ability to respond quickly and to a changing regulatory environment.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
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 WES.
Currently Catalent participates in the Ontario Immigrant Nominee Program (OINP) on a limited basis
While performing the responsibilities of the job, the employee is required to talk and hear. 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.
Pay:
The final salary offered to a successful candidate may vary within this range $65,000 - $81,000, 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 DisabilityAccommodations@catalent.com. 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.