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Supervisor, Quality Assurance

Position Summary:

Catalent is a global, high-growth, public 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 manufacturing. 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 in Kansas City, MO is hiring a Quality Assurance (QA) Supervisor in Clinical/Commercial Supply Materials Management. 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. This individual will also manage and oversee a team responsible for the processing and review of batch records, one time shipment/sample shipment requests, certification and release of batches.

This is a full-time salaried position: Monday – Friday with core work hours between 8am-4pm.

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:

• Responsible for releasing supplies for distribution, ensuring batch record documentation aligns with activities performed and is compliant against Catalent procedures

• Manage workload against the schedule for production priorities, working closely with the Scheduling and Production, including coordination of overtime

• Monitor distribution of work within the department, assigning tasks and making adjustments when necessary to meet commitments

• Coach QA staff through day-to-day activities when needed and lead the daily communication meetings. Act as site subject matter expert for “Good Manufacturing Practices” and SOPs related to batch record documentation and release

• Takes initiative to make decisions for QA collectively with the QA team. Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors

• Interact with customers regarding questions, issues, metrics, batch records, etc. Respond to and investigate customer complaints. Assist with customer and government audits, host and lead tours when required

• Track and report metrics and identify trends and predictive models. Review & revise SOPs, batch records, Change Orders and other related documentation

• Other duties as assigned

The Candidate:

• High school diploma or GED is required, but a Bachelor’s Degree in science or related field is preferred

• A Bachelor’s and 3+ years of QA supervisory experience within the pharmaceutical or medical device industry is required. We will also accept a GED equivalent and 5+ years of QA supervisory experience

• Demonstrated ability to lead and develop others in a professional work environment is required

• Working knowledge of cGMP regulations and strong analytical and investigative skills are required

• Proficiency in Microsoft Word, PowerPoint, Excel, Access. Knowledge of TrackWise and JD Edwards software is a plus

• 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

• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 10 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business.

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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .