Raw Material Chemist

Quality Seymour, Indiana


Description

Job Summary:

This position is primarily responsible for the support of the manufacturing and pharmaceutical development groups in the laboratory analysis of raw materials, container/closure and manufacturing equipment cleaning samples according to current analytical procedures, SOPs and laboratory guidelines.

Essential Functions:

• Perform accurate and timely analysis of raw materials, container/closure and manufacturing equipment cleaning samples according to current analytical procedures, SOPs, and laboratory guidelines.
• Document all laboratory testing and maintain accurate and legible notebooks, logbooks, and records.
• Troubleshoot instrument, methods, and techniques for system suitability failures, out-of-trend, and out-of specification data to assist in determining root causes.
• Assist in maintaining laboratory equipment and facilities.
• Perform analytical method transfers with the Analytical Development (AD) / AD Support groups.
• Perform assigned laboratory equipment calibration and preventative maintenance.
• Provide well-written, accurate and timely analysis regarding laboratory investigations.
• Perform all work using appropriate safety measures.
• Peer review of data, reports and notebooks.
• Assist in the evaluation and improvement of analytical procedures, SOP’s and specifications.
• 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 3 years experience in a cGMP laboratory.
• Strong knowledge of cGMPs, USP/NF and FDA Guidelines.
• Excellent oral and written communication skills.
• Able to troubleshoot analytical methods and laboratory instrumentation.
• Hands on experience with NIR, FTIR, UV-VIS, Raman
• Hands on experience with wet chemistry techniques (i.e. Chemical ID, Titrations, etc.)
• Experience with Chromatography Data Acquisition systems and Laboratory Information Systems.
• Working knowledge of Microsoft Word and Excel.
• Demonstrated ability to work as part of a cross-functional team.
• Ability to multitask.

Education:

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

Supervises/Manages:

• None