Tricia has over 25 years of experience working in quality-related positions for numerous industries, which include pharmaceutical and medical device manufacturing and analytical testing. She spent the first 10 years of her career working as a QC chemist/chemistry supervisor at companies such as Pennex Products, General Nutrition Products and Bausch & Lomb. She then transitioned into quality management and has been a quality manager for the past 15 years working for companies such as Haemonetics Corporation, Instrumentation Industries, Inc. and RJ Lee Group, Inc.
As an integral figure in Gateway Analytical’s start-up, Tricia created a quality management system that achieved ISO 9001:2008 accreditation within a year of operation. ASCLD/LAB and ISO 17025:2005 (A2LA) accreditation was then received a year and half later. The quality management system has also been audited by numerous pharmaceutical customers and each audit resulted in new business. Additionally, Gateway was FDA inspected in November 2012 with no 483s.
During her career, Tricia has created and implemented quality systems for four different companies; all of which met quality objectives and intended accreditations (listed below). She has also acted as an independent consultant for both pharmaceutical and forensic testing laboratories.
As a key technical figure for a new drug manufacturer, Tricia was responsible for the documentation and performance of numerous validation studies to include: terminal steam sterilization, compounding, filling, packaging, and cleaning. She was also responsible for method development and validation for in-process and finished product testing.
From a regulatory perspective, Tricia has prepared numerous 510(k)s and a PMA for medical device marketing approval. She has executed both medical device recalls and medical device reports. She also contributed to the preparation of various drug submissions.
Tricia has performed numerous supplier audits to determine approval status, and has been conducting internal audits for the past 15 years. Tricia has been host to over 70 second and third party audits during the span of her career.
Specialized Areas/ Career Highlights
Tricia has established (created and implemented) quality management systems that have achieved the following:
- Accreditation to ISO 17025:2005 (A2LA)
- Accreditation to ASCLD/LAB International (trace evidence)
- Accreditation to ISO 9001:2008 (UL-DQS- analytical testing)
- Accreditation to AIHA (Chemistry, TEM, PLM/PCM, XRD)
- Accreditation to NVLAP (TEM, PLM/PCM)
- Accreditation to NELAC (chemistry, TEM, PLM/PCM)
- Accreditation to ISO 13485:1996 (BSI- medical device)
- Compliance with 21 CFR part 820 (medical device)
- Compliance with 21 CFR part 210/211 (cGMP-pharmaceutical)
- High Pressure Liquid Chromatography (HPLC)
- Gas Chromatography (GC)
- Fourier-transform infrared spectroscopy (FTIR)
- Inductively Coupled Plasma Spectroscopy (ICP)
- Ultraviolet/ Visible Spectroscopy (UV/VIS)
- Atomic Absorption Spectroscopy (AA)
- Various Wet Chemistry Methods
- M.S. Environmental Science and Management: Duquesne University, Pittsburgh, PA
- B.A. Chemistry: Indiana University of Pennsylvania, Indiana, PA
Professional Affiliations and Accolades:
- RAB Certified Lead Auditor- ISO 9001:2008
- Member of American Society of Quality