Catalent
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.
The role
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 ShareVault as needed
Act as audit scribe, record reviewed documents, summarize audit close‑out meeting, and assist in maintaining audit records in TrackWise
Meet agreed deadlines and communicate adjustments as needed
Perform any other duties as assigned
The candidate
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, TrackWise, SharePoint and ShareVault
Good communication and problem‑solving skills
Ability to sit, stand, walk regularly and occasionally lift up to 50 pounds
Why you should join Catalent
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 WellHub 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 DisabilityAccommodations@catalent.com 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 spam@catalent.com for us to investigate with local authorities.
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The role
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 ShareVault as needed
Act as audit scribe, record reviewed documents, summarize audit close‑out meeting, and assist in maintaining audit records in TrackWise
Meet agreed deadlines and communicate adjustments as needed
Perform any other duties as assigned
The candidate
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, TrackWise, SharePoint and ShareVault
Good communication and problem‑solving skills
Ability to sit, stand, walk regularly and occasionally lift up to 50 pounds
Why you should join Catalent
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 WellHub 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 DisabilityAccommodations@catalent.com 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 spam@catalent.com for us to investigate with local authorities.
#J-18808-Ljbffr