- Entry level
- No Education
- Salary to negotiate
Responsibilities include sampling and testing of utility systems (Color, Appearance, Odor, TOC, Conductivity, Bioburden, Endotoxin, Particulates and Moisture), facility monitoring (viable monitoring plates and non-viable particulate), data trending and report generation.
Other responsibilities include in-process samples and compendial final product testing, chemical and microbiological analysis of cleaning changeover samples, testing of biological indicators and media fill readout. The candidate will share maintenance responsibilities with other laboratory personnel such as reagent preparation, media growth promotion, and cleaning of incubators and biosafety cabinets.
Sample and test process water samples, compressed gases and perform environmental monitoring. Evaluate water and environmental samples.
Perform diagnostic tests on recovered process/environmental isolates, including Gram's stain, Oxidase, Catalase, Heat Treatment, etc.
Perform of chemical, bio-analytical and microbiological analysis of in-process samples and final products, including but not limited to: Spectrophotometric Scan, pH, bacterial endotoxin, HPLC, GC, bioburden, final product sterility test, and USP particulate analysis.
Perform C of A analysis of bulk raw materials such as nitrogen.
Participate in validation projects (e.g. control and release of biological indicators) and generate trend charts, test reports, etc.
Perform routine lab maintenance and perform growth promotion on incoming microbiological media for QC and Manufacturing
Support cleaning and maintenance of basic lab equipment.
Ensure that cGMP compliance is followed.
Qualifications: Education, Experience, Knowledge, and Skills:
BS/BA degree, or minimum of 2 years experience in a related industry, or an equivalent combination of education and experience
Experience in performing chemical and microbiological product testing in a cGMP environment preferred
Experience working with water system and environmental monitoring a plus
Work Environment/Physical Demands/Safety Considerations:
Work in office and laboratory environment.
Lift up to 25lbs may be required.
Ability to work off shifts and/or weekends.
Ability to sit, stand and move within work space for extended periods.
May be required to sit at a computer terminal for extended periods.
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.