Vacancy OverviewLab Technician/Quality Control Microbiology – Berkeley, CA
Airswift is an international workforce solutions provider within the energy, process and infrastructure industries. Airswift serves as a strategic partner to our clients, offering a turnkey workforce solution to capture and deliver the top talent needed to complete successful projects by aligning with the unique needs of our clients. With over 800 employees and 6,000 contractors operating in over 50 countries, our geographical reach and pool of talent available is unmatched in the industry and the level of experience, exposure, and expertise that the organization has is unparalleled.
Airswift has been tasked by one of our major pharmaceutical clients to seek a Lab Technician/Quality Control Microbiology, to work in Berkeley, CA, for a 6-month assignment (subject to extension).
This position is to support related QC Assay testing/validation for Inspire-01 project. Perform microbiology (sterility, LAL (Endotoxin), bioburden, identification, virology) assay and validation activities supporting GMP, Clinical, development product release.
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.
• 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.
• 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.
• Demonstrable experience with cGMP and regulatory compliance (FDA, EMA and other international agencies).