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

Technical Consultant #1687


Expertise

  • Experienced cGMP and 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; FDA regulations including 21 CFR 11, 120, 210/211, and 820; plus, ISO 13485.
  • Demonstrates proficiency in reviewing, editing, and writing SOPs, ensuring accuracy, clarity, and compliance with all applicable guidelines.
  • Effective leader and change agent, establishing and motivating highly-efficient, self-directed teams. Write, develop and perform Validation Protocols (IQ/OQ/PQ), with focus to new systems and equipment.
  • Improved overall quality, processes, testing, and personnel efficiencies, while reducing costs yielding savings of more than $1 million a year.
  • Internal and external Lead Auditor for multiple pharmaceutical manufacturing sites and responsible for completion of CAPA items.
  • Perform, develop and validated 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.

Experience

Independent Consultant, Present

Undisclosed Pharmaceutical Company, 2019 – 2022

Manager Supplier Quality Management             

  • Monitor the External and Internal Audit Program for timely completion of required activities, and perform audits of third-party manufacturers and suppliers, to ensure compliance with GMP regulations, contracted business agreements, and company policies.
  • Support Global Product Quality to ensure that all required internal/ external audits are planned and scheduled.
  • Lead and conduct audits of contractors and suppliers to ensure compliance with Global/ Local Otsuka, and applicable regulatory requirements.
  • Ensure that audit documentation is accurate, complete, and issued within the required timeframe.
  • Review and approve CAPA plans for audit observations.
  • Interfaces with Contractors, Suppliers, Tech Operations, Technical Services, Supply Chain, and Clinical Supply Operations to drive quality improvements that minimize the Costs of Quality. 

SQA Services, Inc., Lead Auditor, 2018 – 2019     

  • Performed independent external audits for SQA client companies to ensure their suppliers, vendors are in compliance with applicable regulations, quality agreements, CAPAs, procedures, and all other pertinent requirements.
  • Clinical Label Supplier Companies - GMP Audits
  • Plastics Company (Pharma, Food and other industry supplier) - ISO 9001:2015, GMP, Data Integrity Audits.

CBRE, Upper Merion, PA, 2015 - 2018

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 Institute, Kenilworth, NJ, 2002 - 2003           

Consultant, Document/Data Auditor, Consent Decree                                               

  • 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%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


Credentials

  • Working on Lean Six Sigma Green Belt Certification from "GoLeanSixSigma"
  • American Society for Quality (ASQ) Certified Quality Auditor (CQA), "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

  • E-Board Leader, current Secretary (elected officer), past Newsletter Production Editor and past Program Committee member for section 307, American Society for Quality (ASQ), Princeton, NJ
  • 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.

Education

  • M.S. Chemistry, Seton Hall University, South Orange, NJ
  • B.S. Chemistry, St. Peter's College, Jersey City, NJ
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