Documentation Specialist, Analytical Research & Development
Company: Disability Solutions
Location: Saint Petersburg
Posted on: October 24, 2024
Job Description:
Documentation Specialist, Analytical Research & Development
Position SummaryCatalent 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.St. Petersburg
is our primary softgel development and manufacturing facility in
North America with a capacity of 18 billion capsules per year.
--The featured RP Scherer softgel technology is a proven oral drug
delivery solution to enhance bioavailability of poorly soluble Rx
and OTC drug candidates. --Non-gelatin based OptiShell-- and
Vegicaps-- capsules expand the range of molecules into softgel,
ideal for challenging fill formulation. Within the Catalent
network, we offer a broad range of integrated formulation.The
Documentation Specialist, Analytical Research & Development is
responsible for reviewing, implementing and maintaining change
control to quality documentation per applicable SOPs. The primary
tasks performed by this individual will include managing,
maintaining, writing, and issuing standard operating procedures,
standard test procedures, specifications, analytical methods, and
other quality documents. To accomplish these responsibilities, the
Documentation Specialist, Analytical Research & Development
requires experience and understanding of document change control
procedures and philosophies within a cGMP environment.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, issuance, and closure of Document Change Requests
(DCRs) in accordance with Catalent's SOPs for all quality documents
(i.e. SOPs, Methods, Specifications, etc.).
- Compiling and reviewing all documents associated with new
material qualification.
- Maintenance of the Document Change Request database.
- Serves on site project teams.-- Interfaces with Engineering,
Procurement, Quality Control, Quality Assurance, Process
Development, Project Managers, Validation and Manufacturing
management in support of providing documentation support for new
product introductions and for changes to existing products.
- Ensures that peers and supervisors are informed as to the QA
issues that may arise in the projects that may affect progress
- Support Technical Services/ Engineering/Quality
Control/Validation schedules in accordance with customer and
internal project commitments to minimize disruption of the project
and provide documentation in support of business needs.
- Ensures the adherence to the standards of quality ruled by the
current Good Manufacturing Practices and the Company's Quality
Policies.
- Participates in the creation and review of current and proposed
procedures.
- Other duties as assigned.The Candidate
- Bachelor's degree in a relevant business discipline required.
--A technical background in chemistry is preferred.
- 3+ years' experience with documentation systems, at least 1-2
years in the pharmaceutical industry and a solid understanding of
cGMPs as they apply to documentation systems required.
- Direct, hands-on experience with electronic documentation
systems; knowledge of Documentum is preferred.-- Knowledge of LIMS
systems, familiarity with bar-coding systems, finished goods label
generation, POMS weigh and dispense applications, TrackWise, and
JDE is a plus.
- Proficient technical writing skills are required.
- Must be well organized, an effective communicator at multiple
levels, able to grasp system concepts and communicate their
applications.
- Must be capable of managing multiple projects with time related
constraints in a fast-paced contract manufacturing
environment.
- Must possess strong technical writing skills and be able to
speak effectively before groups of internal and/or external
customers or employees.
- Authoring and modifying SOPs with input from the change
initiators.--
- Exemplary oral and written communication skills.
- Individual may be required to sit for long periods of time,
while reading or preparing documents.-- The individual may also be
required to stand or walk. Ability to work effectively under
pressure with constantly changing priorities and deadlines.--
- Individual may be required to sit, stand, walk regularly and
occasionally lift to 15 pounds; no lifting greater than 44.09
pounds without assistance. Ability to access and move throughout
laboratory, production area(s) and office area(s) and use the
proper safety precautions as required. Ability to use required
office equipment. Specific vision requirements include reading of
written documents and use of computer monitor screen frequently.Why
You Should Join Catalent
- Tuition Reimbursement - Let us help you finish your degree or
earn a new one!
- WellHub program to promote overall physical wellness.
- 152 hours of PTO + 8 paid holidays.
- Medical, dental and vision benefits effective day one of
employment.
- Defined career path and annual performance review and feedback
process.
- Diverse, inclusive culture. Several Employee Resource Groups
focusing on D&I. Community engagement and green
initiatives.
- Dynamic, fast-paced work environment.
- Positive working environment focusing on continually improving
processes to remain innovative.
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives.
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categories.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, Egypt Lake-Leto , Documentation Specialist, Analytical Research & Development, Other , Saint Petersburg, Florida
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