Black Diamond Networks, Andover, Massachusetts July 2017 – October 2017
Quality Engineer Consultant
- Provided Gap Assessment of SOP’s to conform to client’s policies and to current good manufacturing practices (cGMP) 21 CFR Part 211 regulations, and writing and review of validation installation and qualification protocols (IQ/OQ).
ALKU, LLC, Andover, Massachusetts May 2016 – March 2017
Quality Control/Assurance Consultant
- Provided validation documentation (master plans, installation and operational qualification protocols (IQ/OQ), and subsequent reports) for sterile injectable processing site based on ICH Q8 guidelines
- Provided quality assurance documentation (SOP’s and production batch records), for sterile injectable processing site.
- Provided remediation of deviations and CAPA closure for Quality Assurance.
Valsphere, Stevens, Pennsylvania March – May 2016 Quality Assurance Consultant
- Provided review of validation test scripts to comply with cGMP, SOP’s, and 21 CFR Part 820.
The FDA Group, Westborough, Massachusetts October – December 2015
- Provided project leadership and facilitation to client for CFR 820.100 for non-conformance remediation through CAPA investigation writing, review and approval, and Provided FMEA and BRR for manufacturing in the medical device industry.
The Quantic Group, Ltd., Livingston, New Jersey November 2010 – July 2015
Consent Decree Consultant
- Participated in client documentation review of consent decree requirements for batch record review, process validation, IQ/OQ/PQ documentation; laboratory analytical method review; change control; non-conformance investigations and CAPA.
- Provided project leadership, including gap analysis to client for quality systems based on 21 CFR Parts 210, 211, and 820.
Lancaster Laboratories, Inc., Lancaster, Pennsylvania January 2009 – October 2010
Senior Quality Assurance Specialist
- Authored analytical validation protocols and reports.
- Provided review of analytical data to conform to regulatory compliance for 21 CFR Part 211.
Pharma Bio-Serv Consulting, Dorado, Puerto Rico January 2007 – June 2008
- Leadership of product and process transfer and subsequent process validation of direct compression tablets, and gel pharmaceutical processes, including documentation.
Tunnell Consulting, King of Prussia, Pennsylvania October 2005 – January 2007
Senior Consultant - Formulator
- Prepared cleaning validation master plan, test protocols and operating and analytical procedures for direct compression solid dose and creams/ointments to eliminate content uniformity issues.
Pfizer Company, Lititz, Pennsylvania January 1999 – April 2004
Manager Process Technology Group (Contract Manufacturing)
- Leader of teams responsible for product and process technical transfer of pharmaceutical processes from production to contract manufacturing facilities including analytical, process, and DoE for process improvements.
CfPIE (The Center for Professional Innovation and Education), Pennsylvania March, 2018 - Present Course Director
- Provided review of necessary regulatory background (FDA, EMA, CFR, ICH, USP, PhEur) to effectively establish, justify, and defend global active pharmaceutical ingredient (API) and drug product specifications.
Lebanon Valley College, Annville, Pennsylvania
Master of Business Administration (M.B.A.)
Shippensburg University, Shippensburg, Pennsylvania
Bachelor of Science Degree in Education in Biology/Chemistry
ISPE (International Society of Pharmaceutical Engineers)
ASQC (American Society of Quality Control)