Quality Specialist II - Client Audits

Position Summary

Shift: Monday – Friday 8am‑5pm – 100% on‑site. Catalent’s Kansas City facility provides integrated services for oral solid dosage forms and hosts the Biologics Analytical Services center of excellence.

• Back‑up for Quality Specialist, Client Services for pre‑ and post‑audit activities
• Lead pre‑audit meetings with internal stakeholders (Project Management, Operations, etc.)
• Maintain close working relationships with internal stakeholders to meet client needs during audit
• Lead/participate in client audits (on‑site or remote) with a consistent approach
• Demonstrate working knowledge of KCM site SOPs and other GMP documentation
• Respond promptly, accurately, and respectfully to client audit requests; upload documents to Share Vault as needed
• Act as audit scribe, record reviewed documents, summarize audit close‑out meeting, and assist in maintaining audit records in Track Wise
• Meet agreed deadlines and communicate adjustments as needed
• Perform any other duties as assigned

• Bachelor’s Degree, preferably in Chemistry, Biology or related field
• 2+ years of scientific or quality assurance experience preferred
• Knowledge of cGMP regulations and guidelines for pharmaceuticals and biotech industries
• Proficient with Microsoft Word, Excel, PowerPoint, Track Wise, SharePoint and Share Vault
• Good communication and problem‑solving skills
• Ability to sit, stand, walk regularly and occasionally lift up to 50 pounds

• Defined career path with annual performance reviews and feedback
• Diverse and inclusive culture with employee resource groups focused on D&I
• Positive environment focused on continuous improvement and innovation
• Opportunity for career growth within an expanding team
• Paid time off: 152 hours + 8 holidays per year
• Generous 401(k) match and donation matching
• Medical, dental and vision benefits effective day one
• Tuition reimbursement and Well Hub physical wellness program
• Perkspot discounts from 900+ merchants

Equal Opportunity Employer
, including disability and veterans.

Accommodation:
If you require reasonable accommodation for any part of the application or hiring process due to a disability, please email Disabili with the job number, title and location.

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to  for us to investigate with local authorities.