Quality Control Microbiologist Jobs

Job Summary

If you’re interested in Quality Control Microbiology jobs, then this is the best role for you. You will perform microbiology (sterility, LAL (Endotoxin), bioburden, identification, virology) assay and validation activities supporting GMP, Clinical, and development product release. You will also support related QC Assay testing/validation for the Inspire-01 project.

• Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
• Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical, and development products. Responsibility including protocol and report write-up.
• Investigates questionable test results, write protocol deviation report (PDR), and investigate/test plans when applicable. Collaborates effectively with Quality Assurance validation on the method validation approach.
• Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Write protocols, revises SOPs affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
• Thorough knowledge of microbiological analytical methods, and compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
• Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological-related methods.
• Ability to work independently with minimum supervision.

Skills Required

• Prior experience in a QC microbiology testing laboratory.
• Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
• Thorough knowledge of microbiological analytical methods, and compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
• Minimum experience of 2+ years in microbiological method validation in a pharmaceutical or related industry or an equivalent combination of education and experience.
• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
• Ability to work independently with minimum supervision.

Preferences:

• Demonstrable experience with cGMP and regulatory compliance (FDA, EMA, and other international agencies).

Education/Training/Certifications

• Minimum Education bachelor’s degree in microbiology or related science degree or technical field.

Additional Requirements

• Shift Start Time - 08:00 AM
• Must be able to pass drug screen & criminal background check.

Pay Rate/Salary

Starting from $28 per hour and more depending on experience.