Robert Purdy Email & Phone Number

Tonawanda, NY, US

• Authored and revised procedures for processes to ensure practices and testing results are within the compliance laid out by overseeing regulatory agencies guidelines.
• Internal Auditor
• Authored and performed laboratory equipment, process, computerized systems, and temperature mapping validation protocols.
• Assisted in risk assessments and investigational work that corrected manufacturing deviations.

Buffalo, New York, US

• Authored and revised procedures for processes to ensure practices and testing results are within the compliance laid out by overseeing regulatory agencies guidelines.
• Familiarity with cGMP, FDA, NIST, ISO, ICH, and USP guidelines to ensure documents are within compliance.
• Authored and performed cleaning, laboratory equipment, process, computerized systems, temperature mapping, decommissioning, and facility monitoring system validation protocols. Including validation project plans.
• Authored and executed risk assessment and change controls for validated manufacturing equipment, lab instruments, and their related computerized systems.
• Site Response Team for FDA, varying state level Regulatory Agencies, Internal and Customer audits, includes direct auditor interface and back room preparations.

Greifensee, CH

• Customer Service via email and over the phone to assist customers in troubleshooting their instruments.
• Travel to customers site and perform small circuit board and mechanical repairs on various types of balances, titrators, calorimeters, and pH/Conductivity/Dissolved Oxygen meters.
• Detailed record keeping of expense reports using SAP, time management program Concur, and management of inventory.
• Installation of various types of laboratory equipment, maintaining proper documentation, and ensuring the equipment will comply with customer needs along with governing regulatory body guidelines.

Bad Homburg, Hessen, DE

• Team leader to a group of personnel that were responsible for controlled substance testing and product release. Meeting release deadlines and ensuring each product has accurate quality testing results through various.
• Perform analysis of finished product pharmaceuticals using a variety of test methods ranging from Gas Chromatography, Atomic Absorption Spectroscopy, High/Ultra Performance Liquid Chromatography, Titrations, and.
• DEA approved controlled substance access personnel. Oversaw the retrieval, return, testing, accounting, and disposal of varying schedule levels of narcotics.
• Investigative writing into possible quality discrepancies in pharmaceutical products.
• Performing various Microbiology sampling and testing on intravenous pharmaceutical drug products. Sampling would include water, air, cleanroom, personnel, and environment.
• Reviewing and approving Microbiology testing paperwork associated with commercial pharmaceutical products.

Bachelor'S Degree, Forensic Science And Technology

Associate Of Arts And Sciences - Aas, Biology/Biological Sciences, General

Associate Of Arts And Sciences - Aas, Liberal Arts And Sciences/Liberal Studies