Technical Writer – Manufacturing Experience Position Available In Alamance, North Carolina
Tallo's Job Summary: This Technical Writer position requires a minimum of 3 years of experience in FDA regulated manufacturing environments and technical writing roles. The role involves authoring and modifying documents, coordinating approvals, and training employees on document changes. Preferred experience includes PMA Medical Device or NDA Pharmaceutical manufacturing experience. A Bachelor's Degree in English, liberal arts, or a technical field is required. Apply now for this opportunity in North Carolina.
Job Description
Job Description:
? Minimum of 3 years experience in an FDA regulated (cGMP)manufacturing environment? Minimum of 3 years experience in atechnical writing, document control, engineering, or other rolewhere authoring documents represents 25% or more of the role?
Demonstrated ability to work in a highly cross-functional teamenvironment? Demonstrated ability to effectively prioritize basedon 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) Pharmaceuticalmanufacturing environment? Project Management experience?
Experience with SolidWorks or other drafting software REQUIREDEDUCATION- 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 systemin effect within the organization’s diagnostics systems-NorthCarolina Operations Quality System. This position further ensuresthe approval of documents and coordinates the training of affectedemployees on any changes.? Supports PSP, FPP, FEA, Other projectsby taking input from subject matter experts and converting thatinput into new or modified documents within the Quality System.
These documents include but may not be limited to StandardOperating Procedures (SOP?s), Work Instructions (WI?s),Manufacturing Procedures (MP?s), Component Specifications, DeviceHistory Records (DHR?s), Product Development (PD) documents,Validation Protocols and Reports, and any procedures that fallunder the scope of the Currency Review program.? Trains or assistswith the training of affected employees on any new or modifieddocuments. Apply for this great position as a technical writer today! We arean equal employment opportunity employer and will consider allqualified candidates without regard to disability or protectedveteran status.
