Associate, Quality Assurance Specialist

2 days ago


Kansas City, Missouri, United States Catalent Inc Full time
Job Summary:

Catalent Inc is seeking a Quality Assurance Associate to join our team in Kansas City. As a Quality Assurance Associate, you will be responsible for quality oversight of manufacturing floor activities and associated in-process GMP records. You will identify and participate in opportunities to improve processes. The ideal candidate will have 3+ years of experience in a GMP manufacturing environment, with a strong understanding of batch record review, floor QA, and equipment logs. The successful candidate will be able to follow a variety of instructions and have sufficient skills and knowledge in the use of computers and associated technology.

Key Responsibilities:
Perform batch record review and cleaning log review
Complete monthly and daily facility audits
Ensure products are manufactured according to applicable cGMPs, FDA guidelines, and internal SOPs
Identify deviations during manufacturing and provide direction on the appropriate course of action
Review and approve batch documentation to adherence to SOPs and cGMPs
Participate in QA programs, procedures, and controls to ensure products conform to established standards and agency guidelines

Requirements:
High school diploma required with 3+ years of experience in a GMP manufacturing environment
Bachelor's degree in a life science or business-related field with no experience
Experience with batch record review, floor QA, reviewing of equipment logs, and room approvals/line clearances
Ability to follow a variety of instructions and have sufficient skills and knowledge in the use of computers and associated technology

Why Catalent Inc:
Catalent Inc is a global, high-growth company that is a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. We offer a diverse, inclusive culture, a positive working environment, and opportunities for career growth. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and employee.

What We Offer:
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 + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Company match on donations to organizations
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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