Group Leader, Manufacturing Quality Assurance
Company: Disability Solutions
Location: Kansas City
Posted on: May 4, 2024
Job Description:
Group Leader, Quality Assurance, ManufacturingPosition
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:
- 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 assignedThe Candidate:
- 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 experienceWhy You Should Join Catalent:
- 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 HolidaysCatalent 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 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 spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Shawnee , Group Leader, Manufacturing Quality Assurance, Other , Kansas City, Kansas
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