QA Validation Specialist
Company: Catalent, Inc.
Location: Morrisville
Posted on: January 27, 2023
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Job Description:
Position Summary:Catalent Pharma Solutions is hiring a QA
Validation Specialist for our site in Morrisville, NC.This is a
full-time role position: Monday - Friday, days.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 Research Triangle Park (RTP) facility is Catalent's
Center of Excellence for Analytical Services and is also home to
Catalent's Inhalation franchise including product development,
clinical and commercial manufacturing for pMDI, DPI and Nasal
Sprays.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 Review and
approve computer validation projects related to authoring and
executing specifications and validation documentation for
laboratory automated equipment and systems according to the GAMP5
Validation Life Cycle (URS, FRS, DS (Software and Hardware),
Commissioning, IQ, OQ, PQ), and other validation reportsReview and
approve risks assessments and applicable test scripts according to
GMP and 21 CFR Part 11 compliance guidelines and the Site
Validation Master Plan Review and approve computer system
validation on specific laboratory equipment such as HPLC's, Empower
documents, etc.Perform all other tasks according to "standard work"
as defined by reporting manager.The CandidateBS in Engineering,
Chemistry, or other related scientific discipline5+ years of
experience with reviewing GMP documentsMust have knowledge of
current industry expectations of validation requirements for
process validation, cleaning validation, computer validation, and
equipment qualificationAbility to handle multiple projects and
deliver on project timelines with supervisionKnowledge of all
current cGMP requirements in the US and other parts of the
worldUnderstanding of statistical evaluation toolsSelf-starter who
exhibits a professional demeanor, enthusiasm, communications, and
the ability to work independently with minimal supervisionSound
knowledge and experience of pharmaceutical industry standards and
requirementsWork well in cross-functional departmentsWhy you should
join Catalent:Defined career path and annual performance review and
feedback process Diverse, inclusive culture 19 days of PTO + 8 paid
holidaysDynamic, fast-paced work environmentPositive working
environment focusing on continually improving processes to remain
innovativePotential for career growth on an expanding team within
an organization dedicated to preserving and bettering lives
Competitive salaryCommunity engagement and green initiatives
Generous 401K match and Paid Time Off accrual Medical, dental and
vision benefits effective day one of employment Tuition
Reimbursement GymPass program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately
900+ merchants in a wide array of categoriesCatalent 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, Inc., Cary , QA Validation Specialist, Other , Morrisville, North Carolina
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