Location: Kansas City,MO, USA
Group Leader, Manufacturing 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 Clinical Delivery Services and Biologics Analytical 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, Manufacturing Quality Assurance. The Group Leader will support commercial manufacturing by providing instruction, guidance and direction to others. The Group Leader will address work issues at the individual, team, and department level and have the opportunity to work with many of Catalent's clients to support Quality Strategy.
This is a full-time position: Monday - Friday, flexible outside of core business hours 9am-3pm.
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:
* Reviews and tracks investigations/deviations, corrective actions & effectiveness checks. Participates in Rapid Response Meetings to evaluate Root Cause Analysis as appropriate
* Ensures that products are manufactured, tested, and released according to applicable FDA guidelines, regulations and GXPs and internal SOP's (Standard Operating Procedures)
* Participates in the development and maintenance of QA programs, procedures, and controls to ensure that products conform to established standards and agency guidelines
* Use EDMS (Electronic Document Management System) to review and approve documents. Performs final batch record review, product release, and disposition
* Provides leadership and guidance to the Commercial quality team. Responsible for the oversight of Quality Support functions with manufacturing of products
* Train, coach and/or mentor others on technical, personal development or business issues. Responsible for QA advisement for project outcome and customer interaction
* Participates in the identification, development, and implementation of process related improvements. Develop and execute work plans/schedules for team members, using customer milestones and manufacturing needs. Works closely with Manager to effectively communicate deliverables and resolution of quality issues
* All other duties as assigned
The Candidate:
* A minimum of an Associates degree is required, but a Bachelor's degree in a scientific discipline is highly preferred
* Must have at least 5 years of work experience in a regulated industry, with a minimum of 2 years specifically in GMP Manufacturing Quality Assurance
* ASQ Quality Certification highly preferred
* Proficiency with Microsoft Products is required. Must have experience with SharePoint, TrackWise, EDMS (Electronic Document Management System), or other quality system software
* This position requires the preparation and issuance of reports. The candidate must be comfortable writing concise, logical and grammatically correct audit reports for distribution to internal and external stakeholders
* 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 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.