Nicholas E. Email & Phone Number

United States

-Perform Environmental Monitoring, Bioburden, Endotoxin, pH/Conductivity, and microbial/spore population verification-Perform Biological Indicator, Growth Promotion, Plate Reading, Extraction, Inoculation, Dilution, and Standard Preparation procedures-Perform Microbial Characterization, Gram stain, and subculturing procedures-Make microbial suspensions-Perform dry goods autoclave sterilization cycles-Perform tests to support routine operations and on time report delivery, to troubleshoot equipment and test method issues in strict accordance with Standard Operation Procedures, cGMP, cGLP, and Regulatory requirements-Generate and approve study protocols/test plans for applicable studies-Analyze produced data and generate applicable reports-Coordinate and oversees sampling and laboratory testing execution to produce results in timely manner without compromising quality-Utilize process, technical knowledge and investigation skill to identify and rectify departmental issues-Responsible for the documentation and investigation of laboratory deviations, errors, and out of specifications/out of tolerance results-Facilitate the completion and closure of CAPAs, deviations, and change controls-Ensure labs are clean and safe (in compliance with cGMP) and properly stocked. Inventory of reagents, consumables and materials-Cleaning and maintenance of lab equipment such as glassware, freezers, hoods, incubators, and water baths

Hercules, California, United States

Perform Bioburden, Endotoxin, pH/Conductivity, and microbial/spore population verification-Perform steam sterilization, cleaning and disinfection validation associated testing-Make in-house reagents, stock solutions, media, soil preparations, and microbial suspensions-Perform dry goods, liquid media and biowaste autoclave sterilization cycles-Perform Biological Indicator, Growth Promotion, Plate Reading, Extraction, Pretreatment, Cleaning, Soiling, Calculation, Chemical/Thermal Disinfection, Filtration, Inoculation, Dilution, Neutralization, and Standard Preparation procedures-Perform method development and method development testing-Schedule and/or delivers training to Microbiology personnel in accordance with Department Training Plan to ensure staff can perform assigned tasks correctly, safely, and compliantly-Perform tests to support routine operations and on time report delivery, to troubleshoot equipment and test method issues in strict accordance with Standard Operation Procedures, cGMP, cGLP, and Regulatory requirements-Generate and approve study protocols/test plans for applicable studies-Analyze produced data and generate applicable reports-Coordinate and oversees sampling and laboratory testing execution to produce results in timely manner without compromising quality-Utilize process, technical knowledge and investigation skill to identify and rectify departmental issues-Responsible for the documentation and investigation of laboratory deviations, errors, and out of specifications/out of tolerance results-Ensure labs are clean and safe (in compliance with cGMP) and properly stocked. Inventory of reagents, consumables and materials-Cleaning and maintenance of lab equipment such as glassware, freezers, hoods, incubators, and water baths

Hercules, California, United States

- Perform final QA review on GLP and cGMP studies- Initiate/Investigate CAPAS, deviations, and change controls- Facilitate the completion and closure of CAPAs, deviations, and change controls- Receive and process worksheet requests from departments and deliver requested worksheets once completed- Receive worksheet, electronic form (eForm), logbook form, and standard operating procedure (SOP) revision requests- Open, Process, and publish revised worksheets, eForms, logbook forms, and SOPs - Inspect Laboratory Rooms to ensure equipment, supplies, media, and logbooks are up to date, and within expiry- Perform Good Laboratory Practice (GLP) inspections by observing laboratory technicians perform tests for a specified study and ensure that the test is being performed according to the SOP- Assist/communicate with client auditors and regulatory inspectors related to job duties when required.- Generate trend analysis of the Quality Management System-Assist in the review of data generated by technical departments as well as the Final Report/Report of Analysis- Performing electronic data and audit trail verification when appropriate- Review of equipment qualifications, calibrations, and maintenance records- Initiate and lead investigations for deviations, out-of-specification, and corrective/preventive actions-Assist in the review and approval of unexpected/out of specification notices and investigations generated by technical departments- Review of validation protocols and reports-Assist in processing corrected, amended and/or reissued reports-Assist in Client Dissatisfaction investigations

Hercules, California, United States

- Notify Department Login of projects ready for pickup- Process shipments for internal customer shipping needs- Receive, store, dispense, return, or destroy GLP Test Articles as needed- Sort incoming supply shipments and notify departments of the need for pickup- Schedule courier services for internal pickup- Assist in reconciliation of test article discrepancies- Interact with clients to convey any discrepancies and obtain instructions for resolution of the discrepancies- Receive incoming shipments and segregate supplies from the test article shipments- Receive test articles and enter Laboratory Service Request (LSR) information into the BTD system- Ensure test articles are received and stored at the appropriate storage condition- Ensure information on the LSR matches against the product labeling or identification- Ensure test articles are labeled and stored in a manner to prevent mix-up, cross contamination, or confusion- Perform the return or destruction of test articles- Place test articles with discrepancies into Backlog system and ensure they are followed up on by working with Client Account Managers or the Client until complete resolution of discrepancies or issues allows for the for the processing of the submission- Ensure supplies needed for Login are maintained at adequate inventory levels, placing orders as needed