Senior Specialist I, Quality Assurance
About The Position
Catalent’s Kansas City facility is a leading center for integrated development, manufacturing, and packaging services for oral solid dosage forms. The site combines advanced technologies with a collaborative environment to support pharmaceutical development from early-stage formulation through commercial supply. With a strong focus on quality and innovation, the campus offers modern laboratories, state-of-the-art manufacturing suites, and specialized capabilities to meet diverse client needs. This location fosters teamwork and continuous learning, making it an excellent setting for professionals who want to contribute to delivering life-changing therapies while working in a dynamic and supportive environment. Catalent Pharma Solutions in Kansas City, MO is hiring a Senior Specialist I, Quality Assurance to join our team. In this role, you will perform varied work that requires some evaluation and originality while following established protocols and work plans. You will support quality functions related to manufacturing, ensuring compliance with regulations and internal standards. This position offers the chance to contribute to process improvements and collaborate with internal and external stakeholders in a fast-paced, professional environment.
Requirements
- Bachelor’s or Master’s degree in a scientific discipline or equivalent knowledge and experience.
- 5+ years of Quality Assurance experience in a Good Manufacturing Practice (GMP) manufacturing environment or equivalent experience.
- Complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines.
Nice To Haves
- Six Sigma or American Society for Quality (ASQ) certification preferred.
Responsibilities
- Ensures that products are manufactured, packaged, tested and released
- Performs document generation and review
- Perform product release applicable procedures
- Lead investigator for deviations and complaints
- Perform batch record review
- Performs in-process audits, line clearance, verification of line clearance
Benefits
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement - Let us help you finish your degree or start a new degree!
- WellHub- program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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What This Job Offers
Job Type
Full-time
Career Level
Senior
