Richard Bartkowski Email & Phone Number

Santa Monica, California, Us

Developed, implemented, and maintained quality systems such as change control, deviations, CAPA and supplier qualificationDeveloped and managed a documentation management groupConducted internal audits to ensure quality and compliance for the following departments: manufacturing, material management, facilities, quality engineering, quality control, and supply/sourcingConducted external supplier audits to support the supplier qualification programProvided quality assurance review of quality procedures, analytical methods, and final product/raw material specificationsConfigured, validated, and implemented the Quality Management System, Oracle AgileReviewed and approved manufacturing batch recordsDeveloped and managed a Quality Records group that reviews and approves deviation, laboratory investigation, CAPA, change control, and EV records

Santa Monica, California, Us

Santa Monica, California, Us

Dublin, Coolock, Ie

Managed the laboratory operations on a daily basis, as well as during inspections/audits by the FDA and other regulatory agencies. Managed and developed a staff of laboratory scientists who performed cGMP release and/or stability biochemistry and chemistry testing Managed and developed a staff of laboratory scientists who performed microbiological testing that supported the purified water and environmental monitoring programManaged contract laboratories performing QC testing that support the drug substance and raw material programs; conducted annual audit of all contract laboratories

Seal Beach , Ca, Us

Managed and developed a staff of supervisors and scientists who performed cGMP release and/or stability testing in the following areas: biochemistry, bioassay, cellular analysis, raw material, environmental monitoring, and microbiologyResponsible for ensuring staff remain in compliance of FDA regulated Quality Systems such as Exception Reports, Change Control Records, and CAPAs Directed and/or supported the following corporate programs: product/raw material specifications; raw material program; corporate laboratory investigation procedure; analytical method life-cycle; stability program for cellular product, protein and raw materials; and extractables/leachables program

Managed and developed a staff of supervisors and scientists who specialized in method validations, method transfers, method development, releasing testing, stability testing, and reference standard characterizationManaged Fortune 500 pharmaceutical client projects by constructing project timelines, developing strategies, and leading triage meetings to solve technical issues

Thousand Oaks, Ca, Us

Managed and developed a staff of scientists/project managers who specialized in method validations, method transfers, method revisions, document change control, and nonconformance investigations

New York, New York, Us

Supervised laboratory analysts in the performance of analytical testing of in-process and finished goods of active pharmaceutical ingredients (APIs) in a GMP environment

New York, New York, Us

Developed and validated analytical methods for the evaluation of protein drug formulations and drug substances, (methods included size exclusion, ion exchange, and reverse phase chromatography)

Bachelor Of Arts, Biochemistry

Master Of Arts - Ma, Management