Veterans Preferred - Documentation Specialist, Technical Services
Location: Saint Petersburg
Posted on: November 17, 2021
Military Veterans are Encouraged to Apply. Job Description
Catalent hires people with a passion to make a difference to the
health of millions of people globally. Your expertise, coupled with
Catalent's advanced technologies and collaboration with thousands
of innovative pharmaceutical, biotech and healthcare companies,
will help bring life-enhancing products to the people you know and
love. Your talents, ideas and passion are essential to our mission;
to develop, manufacture and supply products that help people live
better, healthier lives. Interested in learning more about life at
Catalent? Start here
Documentation Specialist, Technical Services
St. Petersburg is our primary soft gel development and
manufacturing facility in North America with capacity of 18 billion
capsules per year. Within the Catalent network, we offer a broad
range of integrated formulation and analytical services to solve
difficult development and manufacturing challenges.
Technical Services is responsible for providing commercial
technical support over the lifecycle of all products, driving
continuous improvement throughout the manufacturing environment,
facilitating commercial technology transfers and ensuring Launch
Excellence during the new product introduction process.
This position is responsible for reviewing, writing, implementing
and maintaining documentation such as batch records, protocols, IPC
recipes, technical assessments and electronic weigh and dispense
system per applicable SOPs. To accomplish these responsibilities
requires experience and understanding of document change control
procedures, computer systems, and manufacturing process knowledge
within a cGMP environment.
If you share a passion for patient care in the growing world of
pharmaceutical manufacturing and would like to be part of a global
drug development and delivery leader, then this might be for
- Review, write, or revise master batch records to support new
products via technical transfers and initiate improvements/updates
for existing commercial products.
- Review, write or revise Technical Services protocols to support
technical transfers, qualification of alternate suppliers,
manufacturing gap assessments or other protocol-driven tasks for
the Technical Services department.
- Review, write or revise IPC recipes for new products or
existing commercial products. Review, write or revise electronic
weigh and dispense system recipes (POMS). Review, write, or revise
technical assessments with input from department SMEs. Review,
write, or revise SOPs with input from the change initiators.
Review, write, or revise Change Control in accordance with
- Addend master batch records prior to execution in support of
Technical Services protocols and other associated
- Maintain all Technical Services documents, electronically or
physically, for immediate, rapid retrieval.
- Electronically scan completed Technical Services documentation,
- Perform training on documents with cross-functional teams, as
- Participates in the creation and review of current and proposed
procedures. Ensures compliance with cGMPs and departmental
- Proposes and assist in the implementation of quality
improvements to document control systems.
- Other duties as assigned.
- Requires a Bachelor's degree in a relevant business discipline
or equivalent experience, or applicable combination. A technical
background and/or degree in a science (including computer science)
- A minimum of 3 to 5 years' experience with documentation
systems is preferred (authoring documents in the systems and
maintaining the systems), at least 1-2 years in the pharmaceutical
industry is preferred.
- Understanding of cGMPs as they apply to documentation
- High-level understanding of manufacturing processes.
- A minimum of 1-2 years of experience authoring written and
electronic batch record recipes is preferred.
Why you should join Catalent
- Cross functional exposure to other areas of Operations
- Medical, Dental, Vision and 401K are all offered from day one
- 152 hours of paid time off annually + 8 paid Holidays
We will identify candidates based on the following Catalent
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
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.
Catalent is committed to the health and safety of its employees,
visitors and the customersand 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 www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin,
disability, protected veteran status, sexual orientation or gender
identity. 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 firstname.lastname@example.org for us
to investigate with local authorities.
Keywords: Catalent, St. Petersburg , Veterans Preferred - Documentation Specialist, Technical Services, IT / Software / Systems , Saint Petersburg, Florida
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