Quality Control Microbiologist

Quality Control Microbiologist M/F (30027)

WHAT WE ARE LOOKING FOR

We are looking for a Quality Control (QC) Microbiologist to join our team. In this role, the key areas of focus will be performing in process, water and finished product QC microbiology testing in the Microbiology Lab, managing environmental monitoring program and performing micro investigations. The ideal candidate will be goal driven, be able to provide support to the team, take initiative and drive change.

YOUR ROLE

General

Responsible for API and Water testing with expertise in at least the following methods of analysis: Total Viable Count, Endotoxin Testing using Gel Clot and either Kinetic Chromogenic or Kinetic Turbidimetric methods, Coliform Testing

Coordinate and perform environmental monitoring of packaging areas

Investigate QC and API Manufacturing microbiology issues with support of QC Lead and Group Microbiologist

Conduct analytical validation of microbiological methods

Introduction of new techniques to the lab, including method transfers, validation protocols

Train QC Chemists in appropriate microbiology test methods and procedures

Other project work as determined by Quality Control Lead

Support other QC tasks as required

Compliance

Strict adherence to Aseptic techniques including sampling

Strict adherence to GMP, including SOPs and Standard Works and where relevant, use of Pharmacopeial standards

Key role in microbiology related risk assessments

Adhere to the site safety program

Continuous Improvement

Continuously improving the efficiency and performance of the QC Microbiology laboratory through:

Implementation of modifications, improvements and work simplifications as appropriate

Ensuring that investigations and root cause analysis are completed to drive improvements and determine root causes where required.

YOUR BACKGROUND

Education Requirements

Bachelors Degree in Microbiology.

Experience

Minimum 3 years relevant microbiology testing laboratory experience in a GMP/pharmaceutical setting, using hands-on analytical techniques

Analytical Validation

Experience with Contamination Control Strategy for API manufacturing plant with low bioburden / endotoxin limit

Cleanroom design and operation

Aptitude for computer operations essential

LIMS experience advantageous

Demonstrated lean capability advantageous

Change control

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to or you can also call this number