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Technical Writer - Manufacturing Experience

Location: Mebane
Posted on: September 10, 2021

Job Description:

? Minimum of 3 years experience in an FDA regulated (cGMP) manufacturing environment? Minimum of 3 years experience in a technical writing, document control, engineering, or other role where authoring documents represents 25% or more of the role? Demonstrated ability to work in a highly cross-functional team environment? Demonstrated ability to effectively prioritize based on business needs? Mastery of Microsoft Word and Microsoft Excel? Excellent technical writing skills? Must be able to speak, read, and write English fluently



EXPERIENCE PREFERRED-? Experience in a PMA (Pre-Market Approval) Medical Device or NDA (New Drug Application) Pharmaceutical manufacturing environment? Project Management experience? Experience with SolidWorks or other drafting software REQUIRED EDUCATION- Bachelor?s Degree in English, liberal arts curriculum, or a technical field



Responsibilities:


This position authors new documents, modifies existing documents, and phases out obsolete documents via the document control system in effect within the organization's diagnostics systems-North Carolina Operations Quality System. This position further ensures the approval of documents and coordinates the training of affected employees on any changes.? Supports PSP, FPP, FEA, Other projects by taking input from subject matter experts and converting that input into new or modified documents within the Quality System. These documents include but may not be limited to Standard Operating Procedures (SOP?s), Work Instructions (WI?s), Manufacturing Procedures (MP?s), Component Specifications, Device History Records (DHR?s), Product Development (PD) documents, Validation Protocols and Reports, and any procedures that fall under the scope of the Currency Review program.? Trains or assists with the training of affected employees on any new or modified documents.



Apply for this great position as a technical writer today! We are an equal employment opportunity employer and will consider all qualified candidates without regard to disability or protected veteran status.

Keywords: , Durham , Technical Writer - Manufacturing Experience, IT / Software / Systems , Mebane, North Carolina

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