Quality Control

18 hours ago

Berkeley, United States Randstad Life Sciences US Full time

Immediate opportunity for four (4) Microbiologists to test commercial and clinical samples for release In this exciting role, you will learn microbiology assays and have an opportunity to gain exposure to validation of methods. As a Microbiologist in Quality Control, you will directly contribute to safety data for in-process and final container of pharmaceutical products. Apply today and join a team committed to excellence in pharmaceutical manufacturing


Schedule/Shift: 1st shift, Mon.-Fri., Tues.-Sat., and Wed.

Position Type: 1 year contract


Position Overview: Quality Control Microbiology – Perform microbiology (sterility, LAL (Endotoxin), bioburden, identification, virology) assay and validation activities supporting GMP, Clinical, development product release. This position is to support project related QC Assay testing/validation.


Essential Duties and 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.


Qualifications:

  • Bachelor’s degree (BS) in Microbiology or related science degree or technical field.
  • Two (2) or more years of microbiology laboratory experience in pharmaceutical or related industry or an equivalent combination of education and experience.
  • Flexible, efficient, and team oriented
  • Excellent communication skills, both written and verbal

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