What are the responsibilities and job description for the Technical Writer position at Catalent?
Technical Writer
Position Summary:
Work Schedule: Monday-Friday, Days.
100% based on-site in Greenville, NC
Catalent’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.
Technical Writer is responsible for collecting, organizing, formatting and authoring documents. This role will make inputs into the site inventory management system for Manufacturing activities.
The Role:
Work with Subject Matter Expert (SME) to gather the information needed to create new 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 manufacturing events.
Responsible to close out help desk tickets regarding 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.
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.
Other duties as assigned.
The Candidate:
Requires a Bachelor’s degree in a science-related field, Engineering, or Industrial Technology, along with at least one year of relevant technical writing experience; OR Associate degree in a science-related field, Engineering, or Industrial Technology, with at least two year of relevant technical writing experience; OR High school diploma or equivalent with at least three year of relevant technical writing experience.
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.
Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds.
Why you should Join Catalent:
Day one benefits! Medical, dental, vision and 401K benefits effective on your first day.
152 hours of PTO 8 Paid Holidays.
Dynamic, fast-paced work environment.
Opportunity to work on Continuous Improvement Processes.
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 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:
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