Technical Writer
Company: Disability Solutions
Location: Greenville
Posted on: February 2, 2025
Job Description:
Technical WriterPosition SummaryCatalent's Greenville, N.C.
facility specializes in end-to-end turn-key solutions for oral
solid dosage forms, including integrated formulation development,
analytical services, commercial manufacturing, and packaging. This
state-of-the-art facility has had over $100M of investments in
recent years and features fit-for-scale capacity with potent
handling capabilities, ideal for orphan or targeted drug
development. 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 Technical
Writer is responsible for collecting, organizing, formatting and
authoring Technical Services documents. This role will make inputs
into the site inventory management system for Pre-Commercial
Manufacturing activities. The Technical Writer will support
Technical Services and coordinate document approval across the
organization; provide lean and agile response to changing
priorities in service of multiple business units for both packaging
and manufacturing activities.Catalent, Inc. is a leading global
contract development and manufacturing organization (CDMO) whose
mission is to develop, manufacture, and supply products that help
people live better and healthier lives. Catalent is dedicated to
delivering unparalleled service to pharma, biotech, and consumer
health customers, supporting product development, launch, and full
life-cycle supply. With time-tested experience in development
sciences, delivery technologies, and multi-modality manufacturing,
Catalent supports the acceleration of development programs and the
launch of more than a hundred new products every year. Powered by
thousands of scientists and technicians and the latest technology
platforms at more than 40 global sites, Catalent supplies billions
of doses of life-enhancing and life-saving treatments for patients
annually.The Role
- Work with Subject Matter Expert (SME) to gather the information
needed to create new Technical Services documents or updates of
existing documents (i.e. Master Batch Records and protocols) and
coordinate associated change control documents.
- Review documents with SME and Operations personnel to ensure
they are accurate, executable and the formatting is consistent and
harmonized.
- Ensure the documentation database is accurate and inputs
conform to company standards.
- Ensure and assist in making inputs to the Manufacturing
Resource Planning in preparation for Technical Services
manufacturing events.
- Responsible to close out Technical Service help desk tickets
regarding Technical Service document corrections and updates.
- Provide requested information during client and FDA
audits.
- Participate and contribute to the activities of the cross
functional project development teams.
- Participate and contribute to the continued implementation of
electronic document software system.
- All other duties as assigned.The Candidate
- Bachelor's degree in a Science-related field, Engineering or
Industrial Technologies with at least 1 year of relevant experience
preferred; previous technical writing experience
preferred--or;
- Associate degree in a Science-related field, Engineering or
Industrial Technologies with at least 2 years of relevant
experience preferred; previous technical writing experience
preferred or;
- High school diploma or equivalent with at least 3 years of
relevant industry experience; previous technical report writing
preferred.
- Ability to administer quality system programs and
resources.
- Familiar with GMP documentation requirements.
- Proficient with Microsoft Office Word and Excel and Adobe
Professional.
- Experience with database management software.
- Effective presentation/communication skills, project/resource
management skills.
- Demonstrated ability to handle multiple priorities.
- Position requires the ability to occasionally lift 10 lbs
unassisted.
- Majority of work day is performed while standing, walking, and
sitting.
- Requires the use of hands for simple grasping and fine
manipulations.
- Ability to occasionally climb and have full range of motion in
upper and lower extremities.--Why You Should Join Catalent--
- Competitive medical benefits and 401K--
- 152 hours of PTO + 8 Paid Holidays--
- Dynamic, fast-paced work environment--
- Opportunity to work on Continuous Improvement ProcessesCatalent
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, Wilmington , Technical Writer, IT / Software / Systems , Greenville, North Carolina
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