Prepare and review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.
Support Process Owners in the development and streamlining of content.
Work with subject matter experts and key functional department personnel to ensure timely development and accurate content of required documentation.
Recommend revisions or changes in scope, formatting, and content as identified.
Perform Quality Control reviews on process document content and formatting.
Maintain and coordinate activities related to the document creation using the EDMS including document initiation, workflow support, revision, and retirement.
Qualifications
Bachelor's degree + 7 or more years of relevant work experience in Quality within the Pharmaceutical/Biotech industry is required; OR Associate’s degree + 9 or more years of relevant work experience in Quality within the Pharmaceutical/Biotech industry is required.
Direct experience in technical writing, specifically SOPs, Work Instructions, Job Aids, etc. is required.
Direct experience in GXP compliant quality systems is required.
Experienced in Microsoft office applications is required.
Excellent written and verbal communication skills is required.
