Technical Writer
Company: Disability Solutions
Location: Morrisville
Posted on: September 28, 2024
Job Description:
Position Summary:Catalent Pharma Solutions is Morrisville, NC is
hiring a Technical Writer for the Manufacturing and Production
Group. The Production department is responsible for the production
of Dry Powder Inhalers and Nasal products within Catalent,
Morrisville, North Carolina. This includes setup, operation,
changeover, and routine maintenance of automated and manual
equipment. The Production department executes, completes, and
reviews all associated master batch record documentation; creates
and reviews standard operating procedures; creates manufacturing
metrics documentation and assists with process development and
validation studies. The Technical Writer supports the manufacturing
of Phase 1, 2, and 3 for clinical and commercial supplies, working
closely with Quality and Operations Management.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
- Perform investigations; write problem reports prior to QA
review; write and complete CAPAs, deviations and change controls;
interact with customers as needed
- Create and revise standard operating procedures for Production;
revisions may be related to process improvements, customer requests
and/or audit observations; create and revise procedures for new
equipment and batch manufacturing
- Create and revise master batch records including interacting
with other departments and customers as necessary; assemble batch
related documentation and complete reviews prior to transfer to
Quality Assurance; develops proper documentation for batch
production
- Interact with Quality Assurance and other functional areas to
ensure timely closure of designated batch release investigations;
interact with Production personnel on continuous improvement
projects related to procedures, batch records, or other
assignments; act as coordinator for operations activities including
JD Edwards support, batch record requisition, work order
completion, and some production planning activities
- Compile and maintain metrics related to operations
- Provide training to management and Production personnel to
promote well-written, thorough investigation reports; assist in the
training of Operations Technicians.
- Set annual goals with supervisor to improve job and individual
skills and abilities; maintain a high level of quality of product
and improved established efficiency and yield standards;
participate in problem solving teams to resolve mechanical,
process, and safety issues
- Assist Engineering to develop manufacturing equipment
improvements, quality improvements, and line performance
improvements; identify process deficiencies and recommend
corrective improvements
- All other duties as assigned;The Candidate
- Associates degree is required, Bachelors degree is
preferred
- 3 or more years of related experience required
- Relevant experience working with Dry Powder Inhalation and
Nasal Processes is required
- Background in Quality is preferred
- Experience writing deviations, investigations, CAPAs, and
change controls is preferred
- Experience rewriting and revising batch records is
preferred
- Strong written and verbal communication skills required
- Ability to read, understand, and interpret technical
instructions is required
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 pounds;Why you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 152 hours of PTO + 8 paid holidays
- 401K program with match
- Several Employee Resource Groups focusing on D&I
- 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--
- Community engagement and green initiatives--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
earn a new one!
- WellHub 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.--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, Cary , Technical Writer, Advertising , Morrisville, North Carolina
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