Technical Writer - Manufacturing Experience
Posted on: September 10, 2021
? 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
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
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
Keywords: , Durham , Technical Writer - Manufacturing Experience, IT / Software / Systems , Mebane, North Carolina
Didn't find what you're looking for? Search again!