Technical Writer

Catalent Pharma Solutions•Greenville, NC

3d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.