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Catalent · 2 weeks ago

Quality Specialist II - Client Audits

Kansas City, MO

Full-time

Onsite

Entry, Mid Level

2+ years exp

Catalent is a global leader in drug development and delivery, and they are seeking a Quality Specialist II - Client Audits. This role is responsible for performing client audits and ensuring compliance with internal and external standards while maintaining effective communication with stakeholders.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

CGMP knowledgeQuality Assurance experienceMicrosoft Office SuiteTrackWiseSharePointCommunication skillsProblem-solving skills

Required

Required a Bachelor's Degree preferably in Chemistry, Biology or other related field

Experienced with Microsoft Word, Excel, PowerPoint, TrackWise, SharePoint and Sharevault software system is a must

Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds

Preferred

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

Possess good communication and problem-solving skills highly desired

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

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2022 (1)