Location: Kansas City,MO, USA
Group Lead, Quality Assurance Documentation Systems
Position Summary:
Catalent is a global, high-growth, private company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
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 Group Lead, QA Documentation Systems. The Group Lead, Documentation Systems is responsible for first-line leadership of the site Document Control, Records Center, and Systems Administration departments. The Group Lead will guide work performed by the departments to facilitate achievement of site goals and objectives; and will support and develop direct reports whose functions are to support and maintain applicable site quality systems.
This is a full-time, salary role. This is onsite. This position is a 1st shift role, Monday - Friday, core hours, 9am-3pm, additional hours before or after required.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role:
* Facilitate the implementation, administration, and maintenance of documentation systems including EDMS, TrackWise, and FileTrail
* Management of department processes including controlled document revision, document issuance, document retirement, on- and off-site record archival, record destruction, and quality systems metrics
* Act as a subject matter expert (SME) for the creation/revision of SOPs, forms, and work instructions related to the above processes within the Catalent EDMS
* Support and/or ownership of investigation of deviations related to department systems
* Leadership of site Document Control, Records Center, and Systems Administration departments and personnel
* Support other activities within the Quality Systems department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, and other quality or regulatory activities, as needed
* Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
* All other duties as assigned
The Candidate:
* Bachelor's degree is required
* At least three years of Quality Assurance experience under Good Manufacturing Practices (GMP) regulatory requirements is preferred
* Experience with document control and/or record archiving systems is preferred
* Possesses problem-solving and decision-making skills to identify and solve work-related issues
* Supervisory/Management experience is preferred
* Experience with Microsoft Word, Excel and PowerPoint is preferred
* Experience with TrackWise, SharePoint and other relevant software systems is preferred
* 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 of PTO + 8 paid holidays
* Several Employee Resource Groups focusing on D&I
* Dynamic, fast-paced work environment
* Community engagement and green initiatives
* Generous 401K match
* 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 ...@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 ...@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.