Certified Quality Auditor Consultant: Pharmaceutical Quality Management Systems and FDA Protocols

Technical Consultant #1687

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.
Review, edit and write SOPs, ensuring accuracy and compliance with all applicable guidelines.
Write, develop and perform validation protocols (IQ/OQ/PQ) for new systems and equipment.
Perform, develop and or validate a wide variety of analytical methods.
Supervisor and chemist expert in developing and improving cost-effective analytical and physical testing methods.
Develop and implement auditing - risked-based system that serves as model for global application.
Perform internal, external, CRO audits to meet client requirements and associated GxP compliance.
Operate as lead internal, external auditor for multiple ISO 9002 sites and managed completion of CAPA items.

Independent Consultant, Present

Undisclosed Company, Lead Auditor, 2018 - Present

Performed independent external audits for SQA client companies to ensure their suppliers, vendors are in compliance with applicable regulations, quality agreements, CAPAs, procedures, and any other pertinent requirements.
Clinical Label Supplier Companies.

CBRE, Upper Merion, PA, 2015 - 2018

Project: Compliance Specialist II, Glaxo Smith-Kline (GSK), Regional, N America

Operated as Lead Regional - GSK trained Auditor for US and Canada. Became go-to advisor for compliance of internal process and sub-contractor / vendor / supplier performance.
Performed internal site audits on diverse functional areas, ensuring compliance with contractual and regulatory requirements, policies, procedures, and promoting continuous improvement.
Conducted pre-audit assessments of specific sites, yielding no FDA or other external audit findings.
Performed quality assessments of suppliers and vendors, supporting high satisfaction and / or improvement as measured by local site management and client.
Generated measurable improvements by recommending, promoting, and coordinating implementation of process and work flow improvements.

Johnson Controls Inc., (JCI) Pennington, NJ, 2010 - 2015

Project: Compliance Specialist - Account at Bristol-Myers Squibb
Performed internal audits on diverse functional areas and promoted continuous improvement.
Developed and implemented auditing system that served as model for global application.
Orchestrated and implemented quality agreements with vendors, ensuring JCI / BMS requirements were met.

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.

Credentials

"Certificate in Drug Development & Clinical Research" from MCCC, West Windsor Township, NJ

"Mini-MBA®:BioPharma Innovations", Rutgers Center for Management Development, New Brunswick
Lean Six Sigma Yellow Belt from "GoLeanSixSigma" - Certification
Analytical Instruments/ASTM Methods, including: GC, HPLC, UV/IR, AA, FPD, FID, IR specific, FTIR.
Statistical Process Control (SPC).
ISO 9000 system: standards, documentation and auditing.
Technical writing and presentations.
Software: Word, Excel, Outlook, MS Mail, PowerPoint, Access, Lotus Notes, SAP, C3 (GSK version of Trackwise), Web Design, and SharePoint.

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.