- Providing leadership and guidance daily to clinical and commercial quality manufacturing floor team associates
- Manage quality associates assigned to the GMP manufacturing floor. This includes time reporting, job assignments, performance reviews and training records
- Responsible for the oversight of Quality support functions for manufacturing of products
- Ensures with a clear understanding that products are manufactured according to applicable FDA guidelines, regulations, GXPs and internal SOP's
- Clear understanding of SOP's, cGMPs and GLP's as necessary to accomplish daily task
- Identify deviations during manufacturing and provide direction as to appropriate course of action
- Review and approve batch documentation for adherence to SOP's and GMP's
- Assist with manufacturing floor activities (equipment/room approval, facility compliance)
- Other duties as assigned
- High School Diploma, required; 3+ years Quality Assurance experience in a GMP manufacturing environment
- Bachelor's degree, preferred; 1+ years Quality Assurance experience in a GMP manufacturing environment
- Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
- Individual may be required to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch or crawl, talk, hear and smell and occasionally lift 0-40 pounds
- (PEOPLE LEADER ROLES) 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
- Several Employee Resource Groups focusing on D&I
- Potential for career growth within an expanding team
- Diverse, inclusive culture
- 152 hours of PTO + 8 Paid Holidays
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Group Leader, Manufacturing Quality Assurance - Kansas City, United States - Catalent Pharma Solutions
Description
Group Leader, Quality Assurance,Manufacturing
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 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 Group Leader, Quality Assurance,Manufacturing performs work that is varied and that may be somewhat difficult in character, but usually involves advanced responsibility. Some evaluation, originality or ingenuity is required. The Group Leader, Quality Assurance,Manufacturing follows managers guidance for protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.
The Role:
The Candidate:
Why You Should Join Catalent:
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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 . 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 for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ) .
