Position Summary

The Microbiologist I, Quality Control Product Testing, performs quality control testing of raw materials, in process samples and final products.

Essential Functions (ES) and Responsibilities

• Perform microbiological and chemical testing for product, in-process samples, and raw materials according to approved Standard Operating Procedures (SOP’s).  This testing includes, but is not limited to, Bioburden, Microbials, Bacterial Endotoxin Testing, Microbial Identifications, TOC/Conductivity, Sterility Testing, Growth Promotion and Enumeration of Biological Indicators.
• Perform instrument/equipment calibration or preventative maintenance according to written procedures.
• Participate in material and reagent receipt for the QC Microbiology Laboratory
• Assist in the generation of work order requests
• Assist in performing inventory and ordering, as needed
• Participate in daily and monthly meetings
• Fulfill requests from management for assistance in other matters as needed.
• Accountable for following Standard Operating Procedures (SOP’s) and adhering to cGMP guidelines.
• Utilize cGMP practices in documentation and execution of job functions.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

• Education Requirements: B.S. in Biological Science or related science discipline.

• Experience Requirements: This position requires 0-3 years of experience in a laboratory setting.  Work in a regulated environment (FDA, EPA, etc.) preferred but not required.

• Core Competencies/Behaviors:
  • Familiarity with microbiological testing is desired.
  • Good communication skills, detailed-oriented and able to work well with others are necessary qualities. 
  • The individual should be flexible and be able to handle multiple priorities. 
  • Able to use a personal computer for data entry.  Perform math calculations involving dilutions, fractions, decimals, and percentages. 
  • Understand and follow instructions, record information, find solutions to practical problems or request assistance.
  • Internal: Frequent contact with Manufacturing, Facilities, QA and Receiving personnel.  Frequent contact with management.
  • External: Contact with technical service representatives and vendors may be required. Exercises judgment within defined procedures to determine appropriate action to routine problems. Prioritization of work with direction of QC Management

Preferred Experience

Compliance Requirements (ES)