Principal Representative, QA
Company: Disability Solutions
Location: Bloomington
Posted on: September 28, 2024
Job Description:
We're hiring for a Principal Representative, QA in Bloomington,
IN to implement and maintain the Data Integrity program. 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.--This Principal Representative, QA's primary role
is to support the data integrity program, and compliance
initiatives. This is a full-time, salaried position and is 100%
site based. The schedule is Monday - Friday, 1st shift.Catalent
Biologics in Bloomington, Indiana--is a--state-of-the
art,--GMP--manufacturing--facility,--providing--one million--sq/ft
of drug substance manufacturing, drug product manufacturing, and
related pharmaceutical services. This award-winning facility helps
customers accelerate biologic drug development programs and bring
better treatments to help patients live better, healthier lives.The
Role
- Responsible to implement and maintain the Data Integrity
Program.
- Assist with the development, execution and approval of System
and Validation Lifecycle Documentation for site GxP systems,
including specifications, test protocols, traceability matrices,
and various assessments.
- Complete review and approval of Computer System Validation
documents in the EDMS system.
- Develop and implement administrative procedures for individual
systems or family of systems through the creation, revision, and
approval of SOPs.
- Review & approve Actions, Change Controls, and Deviations in
the TrackWise.
- Participate in audit trail reviews with System Owners, ensuring
completion on time.
- Complete Data Integrity Assessments.
- Other duties as assigned.--The Candidate
- Bachelor's Degree with 8+ of relatable experience.
- Bachelor's degree in a STEM disciple highly preferred.
- 12+ years of relatable experience, or demonstrated excellence
in role, with justification.
- Minimum of 4 years GxP experience, or other regulated
industry.
- Prior experience supporting data integrity initiatives, in a
cGMP environment, highly preferred.
- A strong working knowledge of quality systems and processes,
preferred.
- Must be able to read and understand English-written job
instructions and safety requirements.Why you should join Catalent
- Medical, dental, vision, and wellness benefits are effective on
the first day of employment.
- Potential for career growth on an expanding team and
organization.
- 152 hours of paid time off annually plus 8 paid holidays.
- Community engagement and green initiatives.
- Engaging D&I Employee Resource Groups.
- Tuition reimbursement program.
- Generous 401K match.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 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, Bloomington , Principal Representative, QA, Other , Bloomington, Indiana
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