Documentation Chemist

Quality Seymour, Indiana


Description

Job Summary:

This position is primarily responsible for the data review for all marketed products. This includes the data for approved products to meet all post-approval stability commitments according to current analytical procedures, SOP’s and laboratory guidelines.

Essential Functions:

Perform accurate and timely data review for finished products, post-approval stability samples, validation and in-process samples according to current analytical procedures, SOP’s and laboratory guidelines.
Review analytical method transfers with the Analytical Development group to Quality Control.
Review laboratory equipment calibration and preventative maintenance.
Assist in maintaining laboratory equipment and facilities
Assist in the evaluation and improvement of analytical procedures, SOP’s 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

Education:

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

Supervises/Manages:

None