What are the responsibilities and job description for the Quality Specialist II - Client Audits position at catalent?
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. 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 The candidate: 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 Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds Why you should join Catalent: 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 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. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: 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. California Job Seekers can find our California Job Applicant Notice HERE. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.