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 Inspire-01 project.

POSITION DUTIES & RESPONSIBILITIES

• 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 SOP's 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.

REQUIREMENTS/PREFERENCES

Education Requirement(s):

• Minimum Education bachelor's 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.

Skill & Competency

• 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).
• Prior experience in a QC microbiology testing laboratory.
• Ability to work independently with minimum supervision.

Preferences

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

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