Principal Qa Representative - Data Integrity
Company: Catalent
Location: Bloomington
Posted on: January 23, 2023
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Job Description:
Principal Quality Assurance Representative - Data
IntegrityPosition Summary: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 Principal
QA Representative is directly responsible for providing support to
the Quality function by overseeing GMP activities, documentation
and reports.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.On Site, Full Time,
Salaried PositionMonday to Friday 1st shiftThe Role Responsible for
Data Integrity Program and Compliance at the Bloomington siteLeads
Data Integrity Projects and Initiatives for the Bloomington site
Responsible for Data Integrity AssessmentsReview & approve items in
our quality systems - CAPA/Deviations/Change control.Work on
special projects to support the business.Maintain Quality Systems,
Processes and facilitiesProvide review and approval of documents in
the EDMS systemProvide direction for and reviewing and approving
deviations, corrective and preventive actions, vendor assessment,
risk assessments and nonconforming material reportsMaintain Quality
Key Performance Indicators (KPIs) for Quality related productsAll
other duties as assignedThe CandidateBachelor's degree or higher
preferred8+ years of experience with Bachelor's degree12+ years of
experience or demonstrated excellence in role with
justificationMinimum 4 years GxP experience or other regulated
industryMust be able to read and understand English-written job
instructions and safety requirements.Why you should join
CatalentDefined career path and annual performance review and
feedback processDiverse, inclusive culture152 hours of paid time
off annually + 8 paid holidaysPotential for career growth on an
expanding team within an organization dedicated to preserving and
bettering livesCompetitive salary with quarterly bonus
potentialCommunity engagement and green initiativesGenerous 401K
match and Paid Time Off accrualMedical, dental and vision benefits
effective day one of employmentTuition ReimbursementOn-site fitness
center and wellness programsCatalent 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.Catalent is
committed to the health and safety of its employees, visitors and
the customers and patients we serve. As a result of the global
pandemic, we have modified many of our recruitment and on-boarding
processes to maintain everyone's safety. The Human Resources teams
will communicate all necessary safety processes and procedures
throughout each stage.personal initiative. dynamic pace. meaningful
work.Visit Catalent Careers 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 disabilityaccommodations@catalent.com. 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.
Keywords: Catalent, Bloomington , Principal Qa Representative - Data Integrity, Other , Bloomington, Indiana
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