Senior Analyst, QA
Company: Disability Solutions
Location: Bloomington
Posted on: October 24, 2024
Job Description:
We're hiring for multiple Senior Analyst, QA roles to support
the investigations 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.--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.--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.A
Senior Analyst, QA --is responsible for investigating and reporting
on major and critical deviations to the manufacturing process,
customer complaints on finished product, and other manufacturing
problems as assigned. This person will interact with multiple
departments to understand a problem, identify root cause(s), and
assist in identifying appropriate corrective and/or preventive
actions (CAPA) to prevent reoccurrence. The Investigator assists
Operations and Quality Assurance teams to determine the disposition
of non-conforming in-process product and determines if a field
alert or recall is required for product that has been released.
This is a full-time, salaried position and is 100% site based. The
schedule is Monday - Friday, 1st shift.The Role
- Pulls together and leads, as appropriate, multi-function teams
to trouble shoot, identify root cause(s) and inform on the
Corrective and Preventative measure for all deviations.
- Reviews the initial triage and RPN score of each assigned
deviation investigation to ensure it aligns with the company
standard and is appropriately classified.
- Works with the Quality unit to address any discrepancies or
concerns with the classification.----
- Required, as appropriate, to seek out and identify, on
location, the processes, equipment and any other areas where a
problem related event occurred to view and understand first-hand
what happened or could happen.----
- Works with the team to clearly identify and communicate the
problem statement that can focus the investigation.
- Effectively work with a team of SME's to quickly identify the
potential scope of an issue and as required escalate to Leadership
to ensure proper actions with customers and regulatory agencies, as
required, are properly made and managed.----
- Conduct interviews in a logical and information seeking way to
help uncover issues and understand the.----
- Identifies first, all possible corrective and preventative
measures through the use of engineering solutions and only moves to
administrative controls after the cost/benefit and compliance risk
are understood and addressed.----
- Completes all investigation information into a comprehensive
deviation report in a manner that clearly defines the problem, the
facts and evidence (including circumstantial) that drives a strong
root cause conclusion, where possible and is linked to clear and
actionable CAPA.----
- Other duties as assigned.The Candidate
- Bachelor's degree in a STEM discipline.
- Master's degree or higher preferred.
- 5-8 years of pharmaceutical manufacturing experience, or
related.
- 2 years of GMP experience, or similar regulated industry,
required.Why you should join Catalent:
- Defined career path and annual performance review and feedback
process.
- Medical, dental and vision benefits effective on 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.
- Competitive salary with bonus potential.
- Tuition reimbursement program.
- Diverse, inclusive culture.
- 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 Analyst, QA, Professions , Bloomington, Indiana
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