Senior Specialist, Quality Assurance IIIPosition SummaryWe have an opportunity for a Senior Specialist, Quality Assurance III to join our team. In this role, you will ensure compliance with quality standards, Good Manufacturing Practices, and regulatory requirements. You will review and approve critical documentation, lead investigations, and support continuous improvement initiatives. This position offers the chance to collaborate with cross-functional teams and provide guidance to ensure product quality and compliance.
Shift: Standard Hours, Monday through Friday
Location: Kansas City, MO
100% Onsite
The Role- Ensure products are manufactured, packaged, tested, released, and shipped in compliance with quality standards, Good Manufacturing Practices, company procedures, and regulatory requirements.
- Perform quality review and approval of batch records, material release documentation, labels, protocols, validation documents, change controls, and other quality system documentation.
- Conduct in-process production inspections, line clearances, shipment verifications, damaged material assessments, annual retain inspections, and label control activities to ensure product quality and compliance.
- Lead and support investigations for deviations, complaints, protocol deviations, and Corrective and Preventive Actions while ensuring timely resolution using risk-based quality principles.
- Participate in continuous improvement initiatives, process enhancements, audit readiness activities, and the development and maintenance of Quality Assurance programs, procedures, and controls.
- Develop and execute work plans and schedules; mentor junior team members; and provide Quality Assurance guidance to support project execution, commercialization activities, and customer interactions.
- Collaborate with cross-functional teams and clients to support validation, data integrity, quality review meetings, equipment qualification, and compliance with established standards and regulatory agency guidelines.
- Perform other duties as assigned.
The CandidateMinimum Requirements- Bachelor's or Master's degree in a scientific discipline with 15+ years of Quality Assurance experience in a Good Manufacturing Practice manufacturing environment or equivalent industry experience, OR
- High school diploma with 20+ years of Quality Assurance experience may be considered.
- 20/30 corrected vision exam with colorblindness testing.
- Respirator fit testing and pulmonary physical.
- Drug Enforcement Administration screening for controlled substance product.
Preferred Skills & Background- Six Sigma or American Society for Quality certification preferred.
Why You Should Join Catalent- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive paid time off plus 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental and vision benefits effective day one of employment.
- 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.
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