Quality Specialist II - Client Audits

Position Summary

• Shift: Monday – Friday 8am-5pm
• 100% on-site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. 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 a Quality Specialist II – Client Audits role. The Quality Specialist II – Client Audits is responsible for performing Client Audits for Catalent Kansas City.

• Back-up for Quality Specialist, Client Services for pre‑ and post‑audit activities
• Responsible to lead any pre‑audit meetings with internal stakeholders, such as Project Management, Operations, etc. to prepare for client audit
• Establish and maintain close working relationships with internal stakeholders to aid in ensuring client needs are met during the audit
• Lead/participate in client audit (on‑site or remote) with a consistent approach
• Demonstrate a working knowledge of KCM site SOPs and other GMP documentation
• Respond promptly, accurately and respectfully to all client audit requests; upload documents to Share Vault as needed
• Act as audit scribe by recording documents reviewed, summarizing audit close‑out meeting including any potential observations for internal distribution; assist in maintaining audit records in Track Wise as requested
• Meet deadlines according to agreed time frames and communicate adjustments as needed
• All other duties as assigned

• Required Bachelor’s Degree preferably in Chemistry, Biology or other related field
• 2+ years of scientific or quality assurance experience highly preferred
• Demonstrated knowledge of regulations and guidelines associated with cGMPs for pharmaceutical and biotech industries preferred
• Experienced with Microsoft Word, Excel, PowerPoint, Track Wise, SharePoint and Share Vault software systems is a must
• Possess good communication and problem‑solving skills highly desired
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds

• 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!
• 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 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.