QC Associate II
6397 Kaiser Dr Fremont, CA 94555
Sunday - Thursday; 11am - 8pm
Day to day duties will include but not limited to, LAL (Endotoxin) and Bioburden testing of in-process samples, raw materials, equipment rinses, WFI and bulk drug substance. Bioburden testing using Membrane Filtration method and Pour plate method. Biological indicator (BI) testing for autoclave validation. Gram staining, and microbial identification of Environmental Monitoring samples, and In Process Testing samples. Growth promotion testing and release of microbiological media. Assist in the preparation of periodic trend reports and analysis of microbiological data. Assist in laboratory investigations of microbiology excursions. Enter data in QC LIMS or other databases in a timely manner. Perform other miscellaneous Lab maintenance activities. Should be able to lift, carry, push or pull up to 50 pounds occasionally. Assist in revising Standard Operating Procedures. Perform GMP document reviews as required. Ensures sampling, testing and release timelines are met. Follows well-defined and established procedures and best practices. Must have experience with GMP and GDP.
- 2 or more years of experience in cGMP regulated industry (Preferably in QC Microbiology lab). Demonstrates proficient computer skills (i.e. documentation systems, databases and spreadsheets), knowledge of Microsoft applications, must be able to use computers to perform data-entry functions etc. Demonstrates excellent interpersonal and communication skills (both written and oral).
- Demonstrates ability to work under minimal direction and as part of a team.
- Demonstrates strong attention to detail.
- Demonstrates good facilitation, organizational and problem-solving skills.
- Must have experience with Pipetting.
- Must have working knowledge of relevant Standard Operating Procedures, U.S. and E.U.
- Good Manufacturing Procedures and other regulatory requirements.
- BS Degree in Science (Preferably in Microbiology).
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.