Microbiologist

1 month ago

Berkeley, United States Randstad Life Sciences US Full time

A major pharmaceutical company guided by our purpose “Science for a better life”, we deliver breakthrough innovations in healthcare. We contribute to a world in which diseases are not only treated but effectively prevented or cured, in which people can take better care of their own health needs. We are helping to drive medical progress through our focus on researching, developing and marketing innovative medicines. Join us to make a better world

Local Candidates only


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 Inspire-01 project.


POSITION DUTIES & RESPONSIBILITIES

  1. 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.
  2. Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
  3. Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
  4. 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.
  5. 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.
  6. Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
  7. Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
  8. Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
  9. Prior experience in a QC microbiology testing laboratory.
  10. 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.

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