Raw Materials 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 HPLC and GC
  • 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