Raw Materials Documentation Chemist

Quality Seymour, Indiana


Description

Job Summary:

This position is primarily responsible for review of data associated with the receipt and testing of raw materials and packaging materials used in the manufacturing of drug products according to current analytical procedures, SOPs and laboratory guidelines.

Essential Functions:

• Perform accurate and timely data review for raw material and packaging material samples according to current analytical procedures, SOPs and laboratory guidelines.
• Review analytical method transfers with the Analytical R&D and Analytical Services groups.
• 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 Lab 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