Microbiologist Mid-Biological RD-RD-PH
Microbiologist Mid-Biological RD-RD-PH
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Salary Not Disclosed
1 Vacancy
Job Description
- Quality Control Microbiology Perform microbiology (sterility LAL (Endotoxin) bioburden identification virology) assay and validation activities supporting GMP Clinical development product release.
POSITION SUMMARY:
- This position is to support related QC Assay testing/validation for Inspire01 project.
- 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.
- Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
- Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
- Investigates questionable test results writes protocol deviation report (PDR) investigation/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.
- Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
- Thorough knowledge of microbiological analytical methods compendial requirements (USP EP JP). Knowledge of biologics and manufacturing processes.
- Strong computer skills (Word Excel Access PowerPoint LIMS SAP).
- Prior experience in a QC microbiology testing laboratory.
- Ability to work independently with minimum supervision.
- Minimum Education bachelors degree in microbiology or related science degree or technical field.
- Minimum Experience 2 years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.
Employment Type
Full Time
