I have 37 years of Quality Control, Quality Assurance and Validation experience with pharmaceutical, biotech and veterinarian products, nutritional supplements, processes, equipment and utilities, plus medical device experience.
As QA Manager for 21st Century Vitamins, Tempe, AZ, from June 2011 to April 2012, I had full responsibility for 10 inspectors on 2 shifts, deciding on their schedules, and rendering quality judgements, generating SOPs and supervising new employee orientation and training.
I performed a small temperature mapping project for Advanced Biohealing, La Jolla, CA, from February to March, 2011, using Kaye Validator equipment for characterizing walk-in incubators and -70C freezers.
I had a validation contract with ProPharma Group, Kansas City, KS to perform design review, and to review previous validation efforts for a sterile syringe filling line, between June and November, 2010.
I was hired as a cGMP consultant for Marlyn Nutraceuticals, Phoenix, AZ, between November 2009 and May 2010. I quickly was made the QC Lab Manager when that position was became available.
As CQT Consultant with Maetrics, LLC., Indianapolis, IN, from August 2006 to August 2009, some of my activities included:
European requalification activities for catheter, guidewire and stent products;
Development of a plant-wide product cleaning program;
Qualification of a reverse osmosis/continuous deionization water purification system used for product cleaning;
Assess corrosion susceptibility for a new implant alloy.
Clients Include:
• Boston Scientific, Maple Grove, MN and Cupertino, CA
• Medtronic Spinal and Biologics, Warsaw, IN
As Senior Validation Specialist, from Sept. 1990 to June, 2002, and Sept. 2005 to June 2006, my responsibilities with Day & Zimmermann Inc, Philadelphia, PA, included CGMP validation support for solid, liquid, biotech and diagnostics products, and medical devices. Some of my LSI project experience includes:
Developed and supervised of the validation of a series of laboratory test procedures for the determination of bacterial endotoxin levels in parenteral products;
Supervised the Installation and Operational Qualification activities for a live vaccine facility, including sterilizers, utilities and environmental areas, in Italy;
Lead the development of solid dosage product process validations for two different firms in Puerto Rico and three in the U.S.;
Developed and executed IOQ and PQ protocols and provided assistance in the development of a process validation strategy for a west coast medical device manufacturer;
Developed and executed Installation, Operational and Performance Qualification protocols for several USP Purified Water systems and Water for Injection systems;
Lead the development of ANADA sections for an animal health products manufacturer in New Jersey;
Lead the development of endotoxin test methods in finished products for an animal health products manufacturer in Kansas;
Developed and executed Installation and Operational Qualification protocols for lyophilized diagnostics products;
Developed and executed IOQ protocols and developed SOPs for a dry cephalosporin filling process;
Developed and executed validation protocols, wrote validation reports and provided on-site support and documentation services for the decontamination of a former penicillin manufacturing facility in North Carolina; Performing routine requalification activities for equipment and processes;
Assisted in batch and product certification activities and contributed to the development of a remedial action plan for a major pharmaceutical manufacturer in Puerto Rico;
Supervised the equipment, cleaning and process validation efforts at an ophthalmic medical device manufacturer in Missouri;
Had full responsibility for directing and coordinating a QA laboratory instrument validation, SOP, PM and calibration project for a multinational manufacturer in Delaware;
Developed numerous Validation Master Plans, estimates and proposals;
HAZMAT Survey of a large manufacturing facility; and
Developed of a process validation strategy for a cultured human tissue for replacement manufacturer, in Massachusetts.
Clients include:
• Bayer Animal Health, Kansas City, KS
• Chiron/Biocine S.p.A., Siena, Italy
• Aventis-Behring, Kankakee, IL
• Amgen, Newport Beach, CA
• Warner-Lambert, NJ. & P.R.
• McNeil, Fort Washington, PA
• TEVA, Sellersville, PA
• Imclone Systems, Branchburg, NJ
• Bayer Biologics, Berkeley CA
• McGann Medical, Goleta, CA
• Lederle, NJ
• Glaxo, Kenly & Zebulon, NC
• Lilly, Indianapolis, IN
• Hartz Mountain, East Orange, NJ
• Fisher Diagnostics, Tarrytown, NY
• Biopure, Franconia, PA
• Storz Instruments, St. Louis, MO
• Kensey-Nash, West Chester, PA
• Organogenesis, Boston, MA
• Astra-Zeneca - Wilmington, DE
As a Senior Validation Engineer, from June, 2002 to July, 2005, my responsibilities with Watson Laboratories Inc., Arizona included:
Performing routine requalification activities for equipment and processes;
Investigate and provide justification for eliminating empty chamber requalifications as a regularly scheduled activity;
Investigate and provide justification for eliminating redundant requalifications by determining ‘worst case’ and ‘equivalencies’;
Conduct studies to assess completeness of existing bodies of documentation of several pieces of equipment, i.e. ‘gap analysis’, and eliminating the deficiencies;
Conduct an assessment of the sterile core with respect to ISO regulations and make recommendations to bring facility into compliance;
Write and execute a variety of Validation protocols;
Lead the introduction of new filter test technology into the facility.
Lead the revision of the facility cleaning validation policy
Prior to joining Day & Zimmermann I was with Colorcon, Inc., North Wales...
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