Specialist, Quality Assurance
Company: Disability Solutions
Location: Kansas City
Posted on: October 24, 2024
Job Description:
Specialist, Quality AssurancePosition SummaryCatalent 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 is hiring a
Specialist, Quality Assurance. The Specialist, Quality Assurance
under general supervision, performs work that is varied and that
may be somewhat difficult in character, but usually involves
limited responsibility. Some evaluation, originality or ingenuity
is required. Follows established protocols and work plans. May be
assisted by laboratory technicians / assistants. Comply with
divisional and site Environmental Health and Safety
requirements.This is a full-time position: Monday- Friday, Days.
Onsite.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 the Quality support functions associated with
the packaging of products for clinical and commercial batches
- Performs batch record review, product release, and
disposition
- Assists in the execution of efficiency improvement projects
with guidance
- Ensures that products are manufactured, packaged, tested and
released according to applicable FDA guidelines, regulations GXPs
and internal SOPs
- Participates in QA programs, procedures and controls to ensure
that products conform to established standards and agency
guidelines
- Ensures gathering of data, investigations and deviations are
timely and compliant
- Follows all Good Documentation Practices and cGMPs to ensure
compliance to applicable FDA guidelines and MHRA guidelines
- Respond and interact with internal and external clients in a
professional and timely manner
- All other duties as assigned;The Candidate
- Required a bachelor's degree in a scientific discipline or
equivalent; OR 6 years of related experience in lieu of a
degree
- Six Sigma or ASQ certification preferred
- Previous experience with root cause analysis and technical
writing is highly desired
- Excellent written and verbal communications skills with
internal and external customers, peers and managers is
required
- Well organized with ability to multitask and work effectively
under pressure to meet deadlines
- 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
- Individual may be required to sit, stand, walk regularly and
occasionally lift up to 50 poundsWhy 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 categoriesCatalent
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 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, Kansas City , Specialist, Quality Assurance, Other , Kansas City, Kansas
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