LSNE, Bedford, NH, QA Consultant, March 2019 – December 2019
- Review and approval of deviation investigations and CAPAs.
- Maintained 100 percent on-time investigation closures.
- Mentoring investigators on root cause analysis.
- Investigation management in Master Control®
Pfizer, Rocky Mount, NC, Aseptic Process Investigator, August 2018 – Present
- Conducting investigations related to events in an aseptic processing environment.
- Closing investigations at a rate on one per week minimum.
- Ghost write investigations for other investigators
- Investigation management in TrackWise®
Menarini Silicon Biosystems, Remediation Consultant, January 2018 – May 2018
- Tasked with execution of supplier multi-phase management program
- Developed and reconciled a new approved supplier list
- Design risk-ranking system for assessment of supplier criticality
- Develop critical supplier qualification program
Cook Medical, Remediation Consultant/CAPA Coach, January 2016 – January 2018
- Nonconformance Team – Assuring 21 CFR 820.90 compliance. Played key role in design and launch of new Nonconformance management system.
- CAPA Coach—Resolved major CAPAs resulting in reduced patient risk and cost reduction.
- Test Method Validation (TMV)—Designed a system for execution of TMVs that resulted in a high probably of first-time-though success and a low possibility of failure.
Ethicon, Program Manager, September 2015 – December 2016
- Managed and upgraded audit readiness tracking program
Bayer Health Care, Six Sigma Master Black Belt – CAPA, June 2015 – August 2015
- Provided guidance for development of project charters and root cause investigations in the DMAIC framework, related to Level 1 CAPAs.
- Cleared backlog of all Level 1 CAPA investigations.
McNeil Consumer Health, Remediation Consultant, May 2012 – December 2014
- Consent decree support.
- Certified Lead Investigator – Conducted investigations from cradle to grave; extensive experience authoring investigation reports.
- cGMP and technical advisor for laboratory operations and as a consent decree verifier (auditor) and lead investigator.
- Responsible for review and verification of lab, stability, cleaning processes/validation and manufacturing operations, and review and classification of complaints.
Novartis, Regulatory SME and Project Manager, September 2011 – May 2012
- Management of FDA remediation projects including program management, validation and justification reports.
- Developed internal release limits based on statistical modeling of drug stability data.
Clients Confidential, Consultant, September 2009 – September 2010
- Designed and wrote, on-time 22 CAPA plans needed for execution of cGMP enhancement program for a biotech diagnostics client.
- Designed and executed method validation scheme for quantification of oligonucleotide-based diagnostics.
- Assisted Pharmaceutical Liquid Dosage Form Manufacturing Client with reduction of HPLC utilization by 10 percent though implementation of alternate analytical procedures for raw material and in-process testing. Result was not having to purchase additional HPLCs.
- Reclaimed 20 man-weeks of laboratory labor through creation of a laboratory aid position, and by use of alternate but equivalent physical test methods for bulk and finished product analysis.
- Designed system for virtual elimination of non-assignable cause laboratory out of specification results.
- Maintained current stability program 100 percent on time.
- Designed cost-reduction program for QC laboratory, resulting in reclaiming 35-man weeks of labor per year.
- Audit by mail and on-site of major suppliers and contract labs, including evaluation of quality agreements and supplier process performance.
- Initiated 5S, SMED and TPM Lean events in preparation for enterprise-wide application of Lean manufacturing.
- Set up complaint handling system (SOPs, training and monitoring).
Johnson-Matthey Pharma Services, Quality Unit Director, September 2008 – September 2009
- Responsible for Quality Assurance, Document Control, Quality Control and Regulatory Affairs for API Manufacturing and Development at Two Sites.
- Supported investigational new drug activities including clinical trials and data management.
- Reorganized QA/Document Control group which eliminated the backlog of over 200 SOP reviews, doubled throughput by creating upstream quality accountability system, and computerized document management systems.
- Improved controlled-document system for issuance and review of use and cleaning logs, laboratory worksheets, and batch records.
- Reorganized management structure of QC Department across both sites. Upgrades in cGMP practices and general procedures have resulted in annual cost savings to date of about $130,000.
- Effective management of CAPA system, investigations and complaints.
- Hosted many client audits. Improvements in Quality Systems have yielded 17 favorable audit results over a 10-month period. Two strategic clients upgraded the company’s supplier rating resulting in increased business opportunities (>1M). Additionally, conducted audits of key suppliers.
- General Quality System improvements include writing a quality manual and a master cleaning validation plan, plus initiating of a Quality Review Board.
- No missed stability intervals and no assignable cause OOS results.
Bio-Pharm, Inc., Director of Quality, May 2007 – September 2008
- Have maintained and increased lab productivity during a 35 percent staff reduction
- Drove design, initiation and completion of:
- Master Validation Plan.
- Plant-wide cleaning validations.
- Concurrent and Prospective process validations.
- Technical transfers
- Annual product reviews for all products.
- Quality Review Board and systems for effective root-cause analysis.
- Investigation, complaint handling and CAPA systems.
- Introduced Six Sigma and Lean practices to the company.
- Provided training on implementation and interpretation of process capability and control charting.
- Developed statistical retrospective validation data for existing products.
- First Kaizen event resulted in 100 percent increase in filling line throughput.,
- Increased output of principal high-speed packaging line from 45,000 bottles per day to over 90,000 bottles per day.
- Created and staffed the Regulatory Compliance group.
- Hosted FDA cGMP inspection and prepared responses to 483 observations.
Various Clients, Consultant, July 2003 – April 2007
- Cleaning validation design and execution, including method development and validation that resulted in client going from Warning Letter to a no 483 follow-up inspection by FDA.
- Complete overhaul of laboratory systems for a prescription drug manufacturer—regulatory and analytical, and, design and implementation of master validation and compliance plan for a major OTC colds product firm, and cost reduction programs via Six Sigma, Lean-based analytical and process flow improvement projects, resulting in a $7,000,000 increase in gross sales.
- Obtained FDA approval for shelf life extensions through statistical treatment of CRT data as per ICH Q1E. Conducted audits of contract labs and lab operations of client companies.
Lycoming Analytical Laboratories, President and Laboratory Director, October 1996 – July 2003
- Managed all technical activities including analytical design, technical review, quality assurance management, supervision of staff, document preparation and review, regulatory compliance, security, supplier audits and customer interaction (sales, workload design, reports, audits, complaint handling and investigations).
- Grew company from startup in January 1997 to a business level of about $1,200,000 per year before sale of company to Chemir Pharma Services in July 2003.
- Successful preapproval inspections for two (2) NDAs and three (3) ANDAs.
- Supported client investigations, through analytical support and consultation, of deviations in tablet and capsule manufacturing process.
- Participated in and supported investigational new drug development including support of clinical trial activities and bioanalytical method development.
- Forensic analytical chemistry work for local law enforcement.
- Textbook, “Managing the Analytical Laboratory; Plain and Simple" 1996, from Francis-Taylor Press
- Textbook, “The Q.C. Laboratory Chemist; Plain and Simple” 1998 from Francis-Taylor Press
- Former American Chemical Society National Tour Speaker
- Former Faculty Member, the Parental Drug Association (PDA)
- Past invited speaker for American Laboratory Management Association, Barnett International and IVC (Advanstar)
- B.S. Chemistry (ACS Accredited), Wagner College
- Certified Lean Six Sigma Master Black Belt (CLSSMBB)
- Certified Lead Investigator, McNeil Consumer Health
- Certification programs in Lean, Six Sigma and Project Management, Villanova University
- Certified Lean Six Sigma Master Black Belt, Villanova University
- American Chemical Society (ACS)
- American Society for Quality (ASQ)