Senior Associate I - Quality Assurance
Company: Disability Solutions
Location: Madison
Posted on: February 5, 2025
Job Description:
Senior Associate I - Quality AssuranceCatalent, Inc. is a
leading global contract development and manufacturing organization
(CDMO) whose mission is to develop, manufacture, and supply
products that help people live better and healthier lives. Catalent
is dedicated to delivering unparalleled service to pharma, biotech,
and consumer health customers, supporting product development,
launch, and full life-cycle supply. With time-tested experience in
development sciences, delivery technologies, and multi-modality
manufacturing, Catalent supports the acceleration of development
programs and the launch of more than a hundred new products every
year. Powered by thousands of scientists and technicians and the
latest technology platforms at more than 40 global sites, Catalent
supplies billions of doses of life-enhancing and life-saving
treatments for patients annually.--The Quality Assurance department
is responsible for all quality assurance and quality control
functions at Catalent, Madison. The Department's primary function
is to ensure compliance with FDA and other regulatory agency
requirements, as well as internal quality systems requirements for
the facility. This includes project review for accuracy and
compliance, systems implementation and maintenance, documentation
management, site-wide systems training, internal and external
auditing, and raw material, Master Cell Bank, and API release.--The
QA Operations Associate assures that all operations at Catalent
meet or exceed cGMP regulations and client customer requirements.
The QA Operations Associate assures the quality of Cell Banks and
Bulk Drug Substance produced and supports release of BDS for
further clinical manufacturing of drug product. This position also
ensures quality of manufacturing and laboratory data and reports.
This is accomplished by direct collaboration and oversight of
Manufacturing Operations and Quality Control and the review/audit
of data and reports as specified by Standard Operating
Procedures.This is a full-time on-site salaried position, Monday -
Friday, 8:00am to 5:00pm CST 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: --
- Serves as 'Quality on the floor' to assist and support
manufacturing staff in detecting and solving compliance errors in
real time
- Audits GMP areas including during production
- Reviews batch records, QC testing records, and all supporting
records
- Reviews ancillary facility and equipment records in support of
GMP operations
- Reviews assay qualification, equipment, and stability
protocols
- Compiles complete batch records through collection of
documentation from multiple sources (production, labs, etc.)
- Identifies and drives resolution of all documentation and batch
record issues to allow for timely release
- Assures the Cell Bank and Bulk Drug Substance are manufactured
and tested in a manner consistent with the applicable regulatory or
client requirements
- Other duties as assignedThe Candidate: --
- Requires Master's degree in STEM discipline with minimum of 0
years related experience OR
- Bachelor's Degree in STEM discipline with minimum of 3 years
related experience OR
- Associate's Degree in STEM discipline with minimum of 6 years
related experience OR
- High School Diploma with a minimum of 7 years related
experience
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 poundsWhy you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives--
- 152 hours of paid time off annually +--8--paid holidays--
- Competitive salary with yearly bonus potential--
- Community engagement and green initiatives--
- Generous 401K match and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition ReimbursementCatalent 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, West Allis , Senior Associate I - Quality Assurance, Other , Madison, Wisconsin
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