Microbiologist (Micro) I, II, & III

Job Description

Job Description

Description:

Position Summary

Microbiologist reports to and takes direction from Microbiology Management. This individual works closely with Management on department strategy and work projects. 

Essential Duties & Responsibilities

• Coordinates      microbiological testing, release of product, and testing for validation      protocols.
• Performs organism      identification.
• Performs technical      review of batch filling records to ensure quality of aseptic processes.
• Reads and interprets      microbiological cultures and other related tests, including but not      limited to environmental monitoring, sterility tests, growth promotion,      and microbial limits tests.
• May perform      validation, technology transfer, and troubleshooting, and write policy      procedures for quality initiatives.
• Reviews and approves      environmental monitoring data, laboratory equipment, and records. Prepares      process and status reports, assigns and monitors document numbers, and      reviews documents for accuracy and completeness.
• Performs other      functions as required or assigned
• Complies with all      company policies and standards

Position Requirements and Qualifications

Minimum Qualifications: A 4-year Bachelor's degree, preferably in a science or engineering discipline

Experience:

• Previous experience      for Micro I (0 to 2 years or more), Micro II (2 to 5 years or more), and      Micro III (5 plus years) in a cGMP biologics/biosimilars manufacturing      laboratory environment is required.
• Working knowledge of      cGMP regulations (21 CFR210/211/820) is desired.
• Working knowledge of      Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ)      is desired.
• Certification from      professional organizations such as ASQ and ISPE is desired but not      required.

SPECIALIZED KNOWLEDGE AND SKILLS: 

• Other special projects      and/or duties may be assigned by Management.
• Trains other Microbiologists on Department methods, processes, and procedures.
• Works with other departments to accomplish Company goals or projects.
• Ability to read and interpret documents such as safety rules, operating and maintenance      instructions, and procedure manuals.
• Ability to write routine reports and/or correspondence 
• Ability to speak effectively before groups or employees of the organization.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form