Mary Chris Easterly Email & Phone Number

Raleigh, Nc, Us

Durham, North Carolina, United States

Durham, North Carolina, United States

Manage site supplier quality management team. Ensure approved supplier list is maintained, supplier changes were assessed for potential product impact, suppliers were qualified, and quality agreements were up to date.

Durham, North Carolina, United States

Conduct quality system internal audits. Lead data integrity audits at global sites. Develop and conduct site auditor foundations and data integrity training for global site auditors.

Durham, North Carolina

Facilitate implementation of new and revised corporate quality systems at Durham Hilleman Center vaccine manufacturing site, including Quality Risk Management, Quality Council, Change Control, Auditing, and more.

29 years of quality assurance and technical roles in diagnostic (medical device), active pharmaceutical ingredient, and pharmaceutical manufacturing industries. Last six years as quality systems auditor for Merck suppliers, contractors, and Merck sites. Audit globally for service providers, manufacturers, distributors, warehouses, laboratories, and more for compliance with applicable good manufacturing practices and controlled substance requirements. Previously internal auditor, supplier… Show more 29 years of quality assurance and technical roles in diagnostic (medical device), active pharmaceutical ingredient, and pharmaceutical manufacturing industries. Last six years as quality systems auditor for Merck suppliers, contractors, and Merck sites. Audit globally for service providers, manufacturers, distributors, warehouses, laboratories, and more for compliance with applicable good manufacturing practices and controlled substance requirements. Previously internal auditor, supplier auditor, and coordinator of audit teams and co-host for client audits and regulatory inspections of contract manufacturing site; approver of GMP documentation; management of supplier quality, internal audit, document control, and change control programs. Experience at Organon Teknika included management of industrial and process engineering, validation, calibration, preventive maintenance, and internal auditing functions. Show less

Present two-day tutorial entitled "Writing Exceptional Audit Reports" at the annual conference of the ASQ Audit Division.

M.S., Quality Assurance

Bs, Industrial Engineering

Activities and Societies: Institute of Industrial Engineering

Education record

Education record