Quality Specialist II - Client Audits

Catalent Pharma Solutions•Kansas City, MO

19d•Onsite

About The Position

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. The role: 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 stake holders to aide 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 ShareVault, as needed Act as audit scribe by recording documents reviewed, summarize audit close-out meeting including any potential observations for internal distribution. Assist in maintaining audit records in TrackWise, as requested Meet deadlines according to agreed timeframes and communicate adjustments as needed All other duties as assigned

Requirements

Required a 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, TrackWise, SharePoint and Sharevault software system is a must
Possess good communication and problem-solving skills highly desired

Responsibilities

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 stake holders to aide 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 ShareVault, as needed
Act as audit scribe by recording documents reviewed, summarize audit close-out meeting including any potential observations for internal distribution.
Assist in maintaining audit records in TrackWise, as requested
Meet deadlines according to agreed timeframes and communicate adjustments as needed
All other duties as assigned

Benefits

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