Senior Representative, QA
Company: Disability Solutions
Location: Bloomington
Posted on: October 26, 2024
Job Description:
We're hiring for a Senior Representative, QA to support our
quality systems auditing team in Bloomington, Indiana!--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.--The Senior Representative, QA will be responsible
for all facility audits and providing support to the quality
systems team. 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.-----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
- Supports customer audits, including co-hosting audits and
providing accurate information regarding the quality systems and
operations; overseeing the audit response follow up actions.
- Participates in internal audits, including coordinating the
audit with relevant department subject matter experts, performing
in-depth assessments of systems and procedures, and communicating
audit findings to key stakeholders.
- Complete Back Room Audit Responsibilities during external
audits; managing and completing requests, contacting and
orchestrating Subject Matter Experts, Preparing documents into
presentable format for auditors.
- Complete Front Room Audit Responsibilities during client
audits; facilitate the audit in lead or support role, manage
positive client relations, actively host client interactions.
- Review and approve responses to audit findings.
- Supports and enhances effectiveness of the quality system,
including reporting metrics; authoring Standard Operating
Procedures (SOPs); identifying improvement opportunities; assisting
with change control, risk management, and corrective and preventive
action processes.
- Supports alignment and improvement initiatives, participating
on cross functional teams to address process improvement, system
improvement, and new regulations / expectations.
- Other duties as assigned.--The Candidate
- Bachelor's Degree in a STEM discipline, highly preferred.
- Minimum of 5 years relevant experience with a bachelor's
degree, required.
- Minimum of 8 years relevant experience or demonstrated
excellence in role, with justification.
- Minimum of 2 years GxP experience, or other regulated
industry.
- Prior experience in cGMP auditing, both internal and external,
highly preferred.
- Robust interpersonal skills, organizational skills, and project
management skills, with the ability to balance multiple priorities
and projects.
- Must be able to read and understand English-written job
instructions and safety requirements.
- A strong working knowledge of quality systems and processes,
preferred.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 , Senior Representative, QA, Other , Bloomington, Indiana
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