Quality Associate II

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year.

Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Pharma Solutions in Kansas City, MO is hiring Associate II, Quality Assurance. The Kansas City Clinical and Specialty Services (CSS) Quality Associate II supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle.

This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.

• Create Certificate of Analysis
• Inspect bulk drug and packaged finished product
• Perform Component Inspection-primary/secondary
• Execute Cleaning Procedures
• Able to interpret and comply with specifications
• Component Release Packets
• Reclass Approvals
• Proficient in JD Edwards (IMS)
• Pre-Batch Record Review
• Post-Batch Record Review
• Post Packaging Study Release

• High School diploma or GED
• 1-3 years packaging experience or related industry experience, preferred
• Receives instruction, guidance and direction from others
• Uses existing procedures to solve routine problems
• Proactive to address work issues at the individual level
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability
• Sufficient skills and knowledge in the use of computers and associated computer technology

• 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!
• Well Hub- program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

This is a full-time, onsite position. This is a 2nd shift position. (Monday-Friday 2:30pm-11pm)

The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring Associate II, Quality Assurance.

Meet the responsibilities and qualifications to support clinical trial projects and ensure compliance with regulatory requirements, cGMPs and SOPs.

• 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.
• Catalent offers rewarding opportunities to further your career, including competitive benefits (medical, dental, vision; 401K matching; PTO; tuition reimbursement; wellness programs).
• Equal Opportunity Employer, including disability and veterans. 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 to Disabili with the job number, title and location.
• Information regarding security and privacy notices for U.S. job seekers and California applicants may be provided as required by law.

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