Documentation Chemist - Analytical Services

Operations Seymour, Indiana


Description

Job Summary:

This position is primarily responsible for the quality control laboratory data review. The data will primarily support updates to compendia procedures, alternate material method validations, current commercial product method updates and pre-commercial stability testing. 

 

Essential Functions:

  • Perform accurate and timely data review.
  • Review analytical method transfers with the Analytical R&D and Analytical Services groups to QC.
  • Review laboratory equipment calibration and preventative maintenance.
  • Assist in maintaining laboratory equipment and facilities
  • Peer review of data, reports, logbooks and notebooks.
  • Assist in the evaluation and improvement of analytical procedures, SOPs and laboratory guidelines.
  • Special projects or other tasks as deemed necessary based on individual’s qualifications, business needs and QC Management’s discretion.

Training or Experience:

  • Minimum of two (2) years of pharmaceutical experience preferred.
  • Knowledge of cGMP, USP/NF and FDA Guidelines.
  • Excellent oral and written communication skills.
  • Exceptional attention to detail.
  • Working knowledge of Microsoft Word and Excel.
  • Experience with Chromatography Data Acquisition Systems and Laboratory Information Systems.
  • Demonstrated ability to work as part of a cross-functional team.
  • Experience with USP compendia procedures and or method validation a plus.

Education:

  • Degree in Chemistry or related field. Relevant experience may be substituted in lieu of degree.

Supervises/Manages:

  • None