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, IQ/OQ/PQ, and decommissioning documents. • 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 chemical disciplines. • 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 various types of physical tests. • 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. • Qualified Trainer in disciplines utilized in a Microbiology lab, including gram staining, antibiotic identification, aseptic technique, proper sampling equipment setup, proper hot liquid, and gas collection.

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