2nd Shift Drug Product and Stability Chemist

Quality Seymour, Indiana


Description

Job Summary:

This position is on Second Shift (3:00-11:30 pm) and is primarily responsible for the quality control analysis and laboratory support for marketed drug products.  This includes the analysis of approved products to meet all post-approval stability commitments.  This also includes the support of manufacturing in the analysis of process verification, validation, in-process, and finished product release samples.  All work is performed in accordance with current analytical procedures, SOPs, stability protocols, and specifications.

 

Essential Functions:

  • Perform accurate and timely analysis of process verification, validation, in process and finished product release samples according to current analytical procedures, SOPs and specifications.
  • Perform accurate and timely analysis of post-approval stability samples according to current analytical procedures, SOPs and stability protocols.
  • Perform analytical method transfers with the Analytical R&D and Analytical Services groups to QC.
  • Perform laboratory equipment calibration and preventative maintenance.
  • Provide well-written, accurate and timely analysis regarding laboratory investigations.
  • Perform all work using appropriate safety measures.
  • Document all laboratory testing and maintain accurate and legible notebooks and records.
  • Peer review of data, reports, logbooks and notebooks.
  • Assist in maintaining laboratory equipment and facilities.
  • Assist in the evaluation and improvement of analytical procedures, SOPs 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 three (3) years pharmaceutical lab experience preferred.
  • Knowledge of cGMP, USP/NF and FDA Guidelines.
  • Excellent oral and written communication skills.
  • Able to troubleshoot analytical methods and laboratory instrumentation.
  • Experience with HPLC and GC.
  • 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