Group Leader, Quality Control

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 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 Leader in Quality Control (Sampling). The Group Leader’s main responsibility is to performs tasks from detailed instructions and established procedures. This individual must comply with site SOPs (Standard Operating Procedures), corporate policies, and Environmental Health and Safety requirements. A strong Group Leader in QC will have applied knowledge of the principles and concepts of multiple disciplines, and he/she will apply technical and functional knowledge to job related duties on projects/assignments within own group/project team. A self-motivated, detail-oriented person who is able to make decisions and solve problems is essential.

This is a full-time salaried position: Monday – Friday, 6:30am-3:00pm.

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:

• Ensure sampling work is performed in accordance with client agreements, internal procedures and GMP (Good Manufacturing Practices) requirements. Support projects by ensuring that sampling timelines are met

• Oversee the daily workflow of sampling activities and draft deviations

• Perform review & verification of data in accordance with in-house SOPs

• Communicate effectively with both internal and external customers, peers and management to facilitate the smooth and timely completion of projects

• Identify and participate in materials management continuous improvement opportunities

• Identify and report cGMP or SOP compliance issues as necessary. Ensure compliance with in-house safety SOPs and work practices

• All other duties as assigned

The Candidate:

• Requires a high school diploma/GED minimum plus 7 years of related work experience. A Bachelor’s degree in chemistry or closely related physical science is strongly preferred with 3+ years of related experience

• 3+ years of relevant experience is required, including: QC batch sampling, QA documentation, GMP regulated products and/or pharmaceutical manufacturing.

• Highly desire previous leadership experience, which may include mentorship rather than direct supervisory role

• Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones is a must

• Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required

• 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 25 pounds

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 152 hours of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• 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

• Competitive salary

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• 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) .