Microbiologist I

Endo•Saint Louis, MO

About The Position

The Microbiologist I is responsible for evaluating material and product quality by performing various procedures in the microbiology laboratory. This individual performs analysis on Raw Materials, Finished Products, Stability, water, and environmental monitoring samples using established analytical methods and is responsible for developing new test methods for the QC Microbiology department.

Requirements

Bachelor’s degree in an appropriate scientific discipline (e.g., microbiology, biology)
Minimum of 3 - 5 years pharmaceutical microbiology experience in a cGMP facility or Master’s degree in an appropriate scientific discipline (e.g., microbiology, biology.
At least 6 years related experience or equivalent technical experience may be considered toward the minimum experience requirement.
Ability to perform multiple tasks simultaneously with accuracy and precision with minimal supervision.
Ability to establish priorities and demonstrate leadership.
Good technical writing and oral communication skills with both team members and other plant support groups
Can work on moderately difficult or demanding tasks and projects
Computer literate with experience in MS Office
Substantial acquaintance with and understanding of application of basic industry principles, theories and concepts
Self-motivated
Team Oriented
Informing
Customer Focus
Listening
Organizing
Function/Technical skills
Peer Relationships

Responsibilities

Provide support for the various projects within the QC Micro Lab- Center of Excellence Department
Assists in the testing of method development and validation for microbial testing
Prepares and executes protocols for method development
Assists in the implementation of new equipment
Ability to support OOS Investigations providing root cause analysis and corrective action for Out of Specification Results
Performs product bioburden testing on incoming raw materials and finished products, as needed
Writes and revises microbiology and other relevant SOP’s, as required
Takes an active role in laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, and auditing
Assists in the training of new team members on testing procedures and compliance regulations.
Primary contact for initial training for lab work and documentation.
Rotates holidays and weekends as necessary to support a 24 hour production facility
Prepares trend reports
Completes organism identifications
Assists with establishing & maintaining safe work standards in the laboratory
Follows site HSE Policies
Peer reviews all levels of work
Follows good documentation practices for the accurate and timely documentation of all activities
LIMS entry of data, approval, and release of data
Use of analytical balance, pH Meter, TOC Analyzer
Maintain instrument readiness
Perform change controls
Ability to troubleshoot equipment and methods in areas of proficiency
Mentor and trainer for all areas of proficiency