Microbiologist (Mid)TekWissen LLC • Berkeley, California, USA
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Microbiologist (Mid)
TekWissen LLC • Berkeley, California, USA
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job_description.job_card.job_descriptionThis position is to support related QC Assay testing / validation for Inspire-01 project. 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. Minimum Education bachelors 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.
Overview :
TekWissen is a global workforce management provider headquartered in Ann Arbor; Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.
Job Title : Microbiologist (Mid)
Location : Berkeley CA 94710
Duration : 12 Months
Job Type : Temporary Assignment
Work Type : Onsite
Job Description :
- Quality Control Microbiology Perform microbiology (sterility LAL (Endotoxin) bioburden identification virology) assay and validation activities supporting GMP Clinical development product release.
POSITION SUMMARY
POSITION DUTIES & RESPONSIBILITIES
REQUIREMENTS / PREFERENCES
Education Requirement(s) :
TekWisen Group is an equal opportunity employer supporting workforce diversity.
Key Skills
Laboratory Experience,Aseptic Technique,Virology,Clinical Laboratory Experience,FDA Regulations,Laboratory Procedures,PCR,Microbiology,Quality Control,GLP,cGMP,Laboratory Information Management Systems
Employment Type : Full Time
Experience : years
Vacancy : 1
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