Mark Mcclain Email & Phone Number

New Mexico, United States

Albuquerque, New Mexico, US

Duties include development of Quality Management System for a dental medical device distributor to compliance with 21 CFR Parts 820, 803, 806, and ISO 13485:2016 standard for medical devices certification management; Management Representative for Management Review meetings, hosting internal audits by sister device manufacturer, CAPA management, software.

I am available for contract audit work for cGMP Auditing & Consulting Services, Medical Devices, Pharmaceuticals & Dietary Supplements.

Abbott Park, Illinois, US

I was an internal compliance auditor auditing divisional compliance sites, affiliate foreign sites, contract manufacturers and various suppliers for the Rapid Diagnostics division. Auditing was to 21 CFR Part 820, ISO 13485:2016, ISO 9001:2015, & ISO 17025:2017 standards.

Waltham, MA, US

Part of an FDA/ISO compliance auditing group auditing cGMP compliance of manufacturing, supplier and toxicology lab sites.

Boulder, CO, US

I worked as a PRN pharmacist at an integrative retail pharmacy practicing allopathic and integrative medicine.I performed patient counseling, giving various IM & SC immunizations, verification of filled prescriptions, oversight of compounded hormonal replacement and veterinary formulations.

My company specialized in cGMP compliance auditing for pharmaceutical, biotech, medical device, dietary supplement and compounding pharmacy firms to ensure compliance with FDA regulations and international guidances. I also conducted contract qualification audits for biotechnology, sterile drug and dietary supplement firms.I can perform mock-FDA.

Denver, CO, US

I staffed per diem pharmacist shifts, handled on-call services and provided oversight of pharmacy technicians sterile IV admixture compounding for home infusion and on-site administration for chronic diseases and genetic deficiencies.

Rockville, MD, US

Duties included managing an Ambulatory Care pharmacy, 12-14 staff of 6 pharmacists and 6 technicians, filling 1200-1300 prescriptions daily, formulary management and a $2 million plus budget. Patient base includes 96,000 Native American patients. Retirement from USPHS is on 7/31/15.

Silver Spring, MD, US

Senior Regulatory Operations Officer performing Good Manufacturing Practice inspections of pharmaceutical and biotechnology companies, medical device manufacturers, compounding pharmacies and included consumer complaint investigations. Level III Pharmaceutical Inspectorate Drug Investigator former dedicated foreign cadre member for foreign inspections.

New London, CT, US

Duties included supervising pharmacy technicians, formulary management, providing ancillary support for 10 collateral duty sites including the Barque Eagle sailing ship, two land-based clinics and two buoy tender ships with independent duty corpsmen. Clinical pharmacy aspects included ambulatory care pharmacotherapy consultations and medication therapy.

Chief pharmacist position with part-time pharmacist employees for a small tribal health center pharmacy with 2 providers.

I was a staff pharmacist for an ambulatory care center and small inpatient hospital next to the University of New Mexico Hospital. We revived the Pharmacist Clinician program which entailed taking a physical assessment course and seeing ambulatory care patients for clinical hours required for licensure. I was not able to finish the program as I saw 175.

Bachelor Of Pharmacy - Bpharm, Pharmacy

Bachelor Of Arts (B.A.), Biology, General