Quality Assurance Supervisor

Quality Assurance Supervisor

Position Summary

• Shift: Monday-Friday 8am-5pm
• 100% on-site

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.

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.

The Quality Assurance Supervisor will manage the day-to-day activities and employees within the Quality Group. This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). This individual will constantly evaluate the internal processes and procedures and work to create an efficient quality area while maintaining the highest possible quality standards.

The role:

• Manage the day-to-day activities and employees within the Quality Group
• Ensure that all work is carried out in accordance with regulatory requirements, cGMP, and Standard Operating Procedures (SOPs)
• Support deviation management activities within TrackWise
• Responsible for releasing supplies for Distribution and ensuring Batch Record documentation aligns with activities performed and is compliant with Catalent procedures
• Interact with customers regarding questions, issues, metrics, and batch records; respond to and investigate customer complaints
• Assist with customer and government audits; host and lead tours when required
• Review and revise SOPs, batch records, Change Orders, and other related documentation
• Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management

The candidate:

• A Bachelor’s degree and 3+ years of QA supervisory experience within the pharmaceutical or medical device industry is required
• Demonstrated ability to lead and develop others in a professional work environment
• Working knowledge of cGMP regulations
• Strong analytical and investigative skills
• Proficiency in Microsoft Word, PowerPoint, Excel, and Access
• Knowledge of TrackWise and JD Edwards software is a plus
• Demonstrable leadership experience at Catalent (e.g., NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered in place of external experience
• Ability to solve unique and complex problems that have a broad impact on the business
• Ability to contribute to corporate and business unit objectives by maximizing resource productivity

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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.