Quality Specialist I

About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a Quality Specialist I to join our team supporting clinical trial projects. In this role, you will help ensure all work complies with regulatory requirements, good manufacturing practices and standard operating procedures. You will be responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This includes ensuring documentation is accurate, current, and properly maintained in line with regulations.

Shift: M-F 10am-6pm
Location: Kansas City, MO
100% Onsite

The Role

- Demonstrate proven competence and ability to flex to the next level for growth opportunities
- Participate in continuous improvement initiatives to enhance processes, systems, and procedures related to quality management
- Inspect components and materials, perform cleaning procedures for sampling, and complete all associated paperwork
- Create Certificates of Analysis with supervision and adhere to GMP standards with guidance
- Review quality control data for completeness and acceptability, approve release packets, and perform material release with supervision
- File batch record documentation, review documents, and perform redactions with supervision
- Support floor quality assurance activities including in-process audits, cleaning, line clearance, and inspections under supervision
- Perform label inspections and releases, and line clearance activities with supervision
- Review and approve quality actions and effectiveness checks, lead investigations for deviations and complaints, and host CAPA review meetings
- Track and trend metrics, perform effective rapid response, and maintain DME training
- Host change control review board meetings, review and approve change controls, engineering studies, and periodic reviews with supervision

The Candidate

Minimum Requirements

- High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment
- Ability to follow instructions and guidance from others
- Use existing procedures to solve routine problems
- Proactive in addressing work issues at the individual level
- Ability to follow written, oral, diagram, or schedule instructions
- Mathematical and scientific reasoning ability
- Ability to identify aberrant data and escalate quality or compliance concerns
- Ability to work effectively under pressure to meet deadlines
- Proficient in using computers and related technology for common tasks
- 20/30 corrected vision exam with colorblindness testing
- Nurse assessment and pulmonary physical
- Respirator fit test
- DEA background check for controlled substance products
- Ability to work in refrigerated (35°F – 46°F / 2°C – 8°C) and freezer (-4°F / -20°C) environments
- Ability to work near machinery and packaging equipment

Preferred Skills & Background

- Bachelor’s degree in a scientific discipline or equivalent knowledge and experience

Why You Should Join Catalent

- Defined career path with annual performance reviews and feedback
- Diverse and inclusive culture
- Potential for career growth within an organization dedicated to improving lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one
- 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an 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, and confirming your request for an accommodation and include the job number, title and location to [email protected] . 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.

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