Position Summary

The Chemist II performs quality control testing of raw materials, in-process goods, and final products with minimal supervision. Uses knowledge of corporate policies to resolve routine problems.

Essential Functions (ES) and Responsibilities

• Perform and quality control testing for raw materials, in-process and final product samples according to approved Standard Operating Procedures (SOPs) and cGMP guidelines.
• Complete testing documentation and data entry as required for procedures and tests performed.
• Apply knowledge to analyzes issues and uses judgment to make decisions.
• Utilize cGMP practices in documentation and execution of job functions.
• Perform instrument calibration or qualification according to written procedures.
• Write and revise SOPs and/or participate in validation Protocol execution, as needed.
• Perform testing as needed to generate data for qualification/validation and special Projects.
• Fulfill requests from management for assistance in other matters as needed.
• Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
• Review documentation on trained tasks as assigned by QC management.
• Use technical and scientific knowledge to recommend solutions to problems.
• Train new hires.
• Maintain inventory to ensure reagents / supplies are available for testing.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements:

• B.S. in Chemistry, Biochemistry, Molecular Biology, or related science discipline.

Experience Requirements:

• At least three years of experience in a laboratory setting.
• Experience working in a regulated environment (FDA, EPA, etc.) is preferred but not required.

Essential Knowledge:

• Familiarity with chemical and biochemical testing is necessary.
• The individual should have experience in one or more of the following analytical instrumentations:
  • HPLC, GC, UV/Vis Spectrophotometer, IR spectroscopy, and/or total airborne and viable airborne particulate counters.
  • Perform math calculations involving dilutions, fractions, decimals, and percentages.
  • Understand and follow instructions, record information, find solutions to practical problems or request assistance.
  • Able to use personal computer for data entry.
  • Internal Contacts: Frequent contact with Manufacturing, Facilities, Receiving, and management.
  • External Contacts: Frequent contact with technical service representatives. Contact with vendors may be required.

Preferred Experience

• Preferred Education: Bachelor’s or Master’s degree in Chemistry, Biochemistry, or related science discipline.

• Preferred Experience: At least three years of experience in a laboratory setting.

Compliance Requirements (ES)