Experience

FDAQRC

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• GMP/GCP auditor

  • Sep 2021 - Present

  Greater Tampa Bay Area



Romark, L.C.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality GMP/ GCP Auditor

  • Mar 2018 - Sep 2021

  Tampa/St. Petersburg, Florida Area Quality Assurance GCP/GMP Quality Auditor GCP Auditor Audit clinical site for compliance to approved stage III study protocol. , Assess compliance risk, focusing on ALCOA by reviewing data entries, patient eligibility, signed consent forms, investigator financial status and review of Institution Review Boards history credential according to CFR requirements. Attended Barnett International clinical research auditing certification program. GMP Auditor Audit… Show more Quality Assurance GCP/GMP Quality Auditor GCP Auditor Audit clinical site for compliance to approved stage III study protocol. , Assess compliance risk, focusing on ALCOA by reviewing data entries, patient eligibility, signed consent forms, investigator financial status and review of Institution Review Boards history credential according to CFR requirements. Attended Barnett International clinical research auditing certification program. GMP Auditor Audit manufacturing processes for compliance with approved regulatory licenses. API and excipient. Batch Record, Validation, Facility& Equipment, Laboratory, Change Control, Training and Packaging and Labeling. Assess compliance risk by conducting internal compliance audits (corp. policies, cGMP stds) Developed/ Implemented corporate wide audit Program. Training sites how to host Regulatory Inspection. Supplier audit for material and services. (ICH, PIC/s) Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Compliance Auditor

  • Feb 2007 - Jan 2018

  Rouses Point, NY Compliance auditor for Pharmaceutical manufacturing facility, responsible for conducting internal and external compliance audits and as a major resource for regulatory requirements. Performed various compliance audits in manufacturing, packaging, warehousing, distribution, engineering, laboratory, and importation activities. Audits include site internal audits, facility audits of sister sites, and supplier audits (raw material excipients and APIs, packaging components, warehouses)… Show more Compliance auditor for Pharmaceutical manufacturing facility, responsible for conducting internal and external compliance audits and as a major resource for regulatory requirements. Performed various compliance audits in manufacturing, packaging, warehousing, distribution, engineering, laboratory, and importation activities. Audits include site internal audits, facility audits of sister sites, and supplier audits (raw material excipients and APIs, packaging components, warehouses). Familiar with major BOH regulations such as FDA, MHRA/EMEA and Health Canada, as well as other accepted regulations and standards (ICH, WHO, USP/EP).Site readiness responsible for Board of Health inspections. Front line host with regards to receiving BOH, corporate and third party inspections.

• Quality Operation

  • Sep 1994 - Jan 2018

  Lab analyst Lab supervisor Compliance officer Compliance auditor