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Supervisor of Quality Assurance Operations
3 months ago
Quality Assurance Supervisor
Position Overview
Catalent is a prominent, rapidly expanding public entity and a key collaborator for the pharmaceutical sector in the creation and production of innovative therapies for patients globally. Your skills, insights, and enthusiasm are vital to our objective: to enhance the quality of life for individuals. Catalent is dedicated to a Patient First ethos through superior quality and compliance, prioritizing the safety of every patient, consumer, and employee. This role presents an exciting chance to significantly influence the strategy for our new pharmaceutical facility and to shape the future of our North American operations.
Reporting to the Director of Quality, the Quality Assurance Supervisor is tasked with managing the daily functions of the Quality Assurance team, ensuring effective resolution of compliance-related quality matters. The Supervisor will oversee the administration of various quality systems to uphold GMP compliance.
Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch break.
Key Responsibilities
Assist in multiple quality system domains, including supplier and material assurance, internal audits, customer regulatory inquiries, change control, document management, and metrics reporting. Lead, coordinate, and engage in investigations and the identification/implementation of corrective actions for deviations and Right First-Time documentation. Ensure timely closure of deviations and corrective/preventative action items. Provide daily oversight of the Quality Assurance teams, including performance management and support for team members in achieving their professional development objectives. Conduct and document training for all team members, ensuring they are sufficiently trained for their respective roles. Responsible for resource allocation for the team based on insights from the Master Production Schedule (MPS) and monthly commitment discussions. Support during regulatory and customer audits, ensuring preparedness and compliance. Ensure that batches released for commercial/clinical purposes fully adhere to regulatory standards and existing policies and procedures. Perform additional duties as required.Candidate Qualifications
A bachelor's degree in a relevant field such as Life Sciences, Engineering, or a related discipline is required (Chemistry, Microbiology, or Pharmacy preferred). An equivalent combination of education and experience may also be considered. Minimum of 3+ years of experience in leading and supervising a team in a Quality Assurance environment, ensuring safety, quality, and productivity. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs) may be considered in place of external experience. Experience in manufacturing, pharmaceutical, and/or GMP facilities is preferred. Strong commitment to workplace safety and a thorough understanding of occupational health and safety regulations. In-depth knowledge of GMP compliance and regulatory requirements with a solid understanding of quality systems. Experience in reviewing and approving controlled documents. Proven track record in supporting regulatory and customer audits, with proficiency in overseeing internal audit processes and conducting compliance reviews. Strong organizational and time management skills to prioritize tasks, allocate resources effectively, and meet operational schedules. While performing the responsibilities of the job, the employee is required to communicate effectively. The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Manual dexterity is required. The employee is 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.Why 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 & personal time. Employee Reward & Recognition programs Opportunities for professional and personal development & growth including tuition reimbursement.Catalent offers rewarding opportunities to advance your career Join the global leader in drug development and delivery and help us provide life-saving and life-enhancing products to patients worldwide. Catalent is an exciting and growing international company where employees collaborate 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 annually, 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 onboarding 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.
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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.
