Michael Grob Email & Phone Number

Tampa, Florida, United States

Responsible for Quality Assurance functions as assigned by company SOPs. Supervise the Document Control Department to ensure all required activities are executed according to cGMP principles and internal procedures. Implement and maintain the company’s calibration/preventative maintenance tracking system. Schedule the calibration of instruments both on-site and by contract calibration services as required. Keep abreast of industry quality trends in cGMPs. Advise company president and laboratory management on project decision points that may affect quality. Participate with equivalent management in developing and recommending company policies and managing company projects. Serve as Quality Control signatory on all applicable technical documents as needed. Act as Safety Officer and Chemical Hygiene Officer. Oversee Quality Assurance/Quality Control systems. Perform internal quality audits of all company departments.

Tampa, Florida, United States

Resident microbiology expert for R&D generic pharmaceutical company. Working environment is a cGMP R&D laboratory. Responsible for all bulk, finished product and stability microbiology testing, including cUSP microbial limits and antimicrobial effectiveness testing. Develop product specific microbial test methods and specifications. Oversee the document control system and act as quality control approval for all test methods, method validation protocols, product specifications and stability protocols. Also conduct USP antibiotic cylinder plate microbiology assays.

Supervised quality control microbiology laboratory at a GMP medical device manufacturing plant. Responsible for microbiological testing of raw materials/finished product/stability and the environmental monitoring of the manufacturing areas. Approved sterile product batch records for release. Conducted sterility assurance process validations for gamma irradiated and ethylene oxide sterilized product. Internal quality auditor. Also audited contract micro laboratory and sterilization service providers. Quality control representative for numerous plant wide projects.