Microbiologist (mid)

Job Summary
Quality Control Microbiology Specialist sought to perform Good Manufacturing Practices (GMP)-compliant microbiology assays and validation activities, including sterility, LAL (Endotoxin), bioburden, identification, and virology testing.

This role will support the Inspire-01 project by ensuring timely and accurate quality control assay testing and validation for Clinical and development product release.

location: Berkeley, California

job type: Contract

salary: $ per hour

work hours: 9 to 5

education: Bachelors

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 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.

Qualifications

• Bachelor's degree in Microbiology or related science degree or technical field.
• 2+ years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.

skills: Microbiology, Laboratory Information Management Systems (LIMS), Aseptic Technique, Good Manufacturing Practices (GMP), Quality Control (QC)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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