- ASQ Certified Quality Auditor (CQA) solving quality issues and improving quality systems.
- Document/Data auditor for Quality Management System, cGMP, GLP, GCP, ICH, EP, USP, NF, DEA, SOPs and protocols.
- FDA compliance in a pharmaceutical environment.
- Internal and external Lead Auditor for multiple pharmaceutical manufacturing sites and responsible for completion of CAPA items.
- Improved overall quality, while reducing costs more than $1 million a year.
- Reviewed, edited and wrote SOPs ensuring accuracy and compliance with all applicable guidelines.
- Write, develop and perform validation protocols (IQ/OQ/PQ) for new systems and equipment.
- Performed, developed and or validated a wide variety of analytical methods.
- Supervisor and chemist expert in developing and improving cost-effective analytical and physical testing methods.
Independent Consultant, Present
CCL Label, Healthcare Solutions Group, Hightstown, NJ, Quality Consultant, 2009
- Wrote, developed and performed validation protocols (IQ/OQ/PQ) for new equipment and systems.
- Reviewed, edited and harmonized all local Quality System Documents (QSD) with higher level QSD.
- Audited operational performance and recommended modification work instructions to ensure actions desired are performed and documented appropriately.
Intertek USA, Inc., Whitehouse, NJ (a CRO company), QA Auditor II, 2004 - 2009
- Performed meticulous and accurate audits of documentation, raw data and statistics, ensuring compliance with protocols, SOPs, USP, ICH, EP, Quality Management System, cGMP, GLP, DEA,and FDA regulations.
- Identified non-conformances in projects (Deviations, Investigations, OOS, etc).
- Audits performed yielded 2% client report reissues compared with 4 to 7% by other auditors.
- Performed internal audits citing, non-compliances and ensured corrections, resulting in fewer reoccurrences.
- Conducted safety audits citing issues and made recommendations, enhancing safety practices and compliance.
- Reviewed, edited and clarified SOPs and protocols resulting in current and ever improving work documents.
Schering-Plough Research, Kenilworth, NJ, Consultant, Document/Data Auditor, Consent Decree, 2002 - 2003
- Professional auditor ensuring compliance with protocols, SOPs, USP, cGMP, GLP and FDA regulations.
- Identified non-compliances. Alerted line management and identified corrective action resulting in improved project quality.
Ashland Chemical, Drew Division, Boonton, NJ, Development Chemist, 2000 - 2002 ~Evaluated competitor products, giving research and development tools to improve/develop products and enter new markets.
- Developed and modified analytical methods to improve company's analytical abilities.
- Traveled to customer sites and developed and instructed customer in enhancing their testing procedures.
Chromak Research Inc., Bound Brook, NJ, Chemist, 1999 - 2000
- Performed analysis of pharmaceutical finished products by USP, NF and in-house testing methods by using HPLC, GC, TLC, UV, IR and wet chemical techniques.
- Developed and validated analytical methods.
- Conducted dissolution testing of solid dosage forms.
- Calibrated/maintained lab equipment to ensure cGMP compliance, participated in troubleshooting resolutions.
BASF Corp., Jamesburg NJ, QA Supervisor/Analytical Chemist II, 1989 - 1999
- Developed and implemented SOPs, enabling "Global Standardized" testing.
- Improved efficiency, accuracy, precision, detection levels and flexibility of analyses by 10-20%.
- Modified and/or developed new GC analytical methods that enhanced analytical capabilities.
- Moved in-process/finished materials testing to raw material/in-process testing, thereby improving prime material by 3% per year and saving $1 million a year.
- Responsible for all quality issues including completion of all CAPA items within established deadlines.
- Mentored staff, leading to their promotion into engineering and product development roles.
- Key contributor to achievement of ISO 9002 certification within a 6-month period.
- Trained ISO 9002 auditor/lead auditor for various sites.
Honors & Publications
Academic and Professional Affiliations
- American Society for Quality (ASQ)
- Trained Examiner for Governor's Award for Performance Excellence via Quality New Jersey
- Toastmasters International - "Competent Toastmaster," former assistant area governor and club president.
- American Society for Quality (ASQ) Certified Quality Auditor (CQA)
- "Certificate in Drug Development and Clinical Research" from MCCC (in-process)
- "Mini-MBA%u2122: BioPharma Innovations" from Center for Management Development, Rutgers
- M.S. Chemistry, Seton Hall University, South Orange, NJ
- B.S. Chemistry, St. Peter's College, Jersey City, NJ