Technical Writer- Analytical Method Validation

Company: Avet Pharmaceuticals
Location: East Brunswick
Posted on: May 3, 2021

Job Description:

Job Summary:

This person currently in this position in AMV is primarily responsible to gather data/results from AMV studies and present in a technical report for submission. Additionally, he is also given the responsibility for assisting in ordering chemicals, standards, and Lab consumables for the AMV group. The person is also responsible to organize and store written protocols, reports, folders with chromatograms/ UV spectrums and books in orderly fashion and archive with the QA group as needed for the AMV group.

Reporting Relationships: This position directly reports to the Associate Manager/Manager of AMV and in-conjunction with the Director for AMV.

Essential Functions: The position includes Over-seeing of the following activities but not limited to: o Prepare Analytical Method Validation/Verification/Transfer Reports for method validation group per written procedures and cGMP Guidelines. o Be able to review Written Technical Protocols and Methods for Method Validation Studies. o Assist method validation department for general tasks including ordering of chemicals, HPLC accessories and other Consumables for the AMV group. o As needed perform additional duties for Quality Control (AMV) Department. o Upkeep the AMV group with respect to organizing and storing written protocols, reports, folders with chromatograms/ UV spectrums and books in orderly fashion and archive with the QA group as needed for the AMV group.

Specialized Skills and Knowledge: Minimum BS in Chemistry or related field. Computer knowledge for executing Words, Excel is mandatory. Report Writing Experience will be considered as a plus.
Prepare and review documentation (reports and other relevant doc.) on new product development with respect to Quality

Keywords: Avet Pharmaceuticals, East Brunswick , Technical Writer- Analytical Method Validation, Other , East Brunswick, New Jersey