Quality Consultant/SME

SUMMARY

  • Twenty-eight years of biological research, project supervision and pharmaceutical consulting; eleven years of which focused on vaccine testing and over six years in quality control supervision.  
  • Seven years experience in supervision of aseptic sterility testing suite and testing of vaccines for sterility (USP <71>), endotoxin (USP <85>) and potency.  This experience included trouble shooting of endotoxin assays for enhancement or inhibition of samples containing complex matrices including protein containing biological preparations and animal serum samples.  
  • Over eight years experience consulting for the pharmaceutical industry primarily in the areas of quality systems, investigation and remediation of environmental monitoring, environmental suite qualification, sterility testing, water testing, endotoxin assay remediation and trouble shooting.  
  • Create Data Integrity documents for micro testing of products and manufacturing environments for cancer treatment product corporation launching their first successful product.
  • Extensive experience with SOPs, data review and approval, investigations, deviations, OOS, risk analysis, CAPA development and implementation, and 483, EIR and warning letter responses.
  • Consulting for Gene and Cell Therapy companies for aseptic suite contamination control and compliance issues.
  • Writing SOPs, Investigations, and Technical reports for EM, sterility and endotoxin remediation projects in accordance with 21 CFR 210/211 requirements, USP 14644 and EMA requirements.  
  • Assist in audits by regulatory agencies, perform internal audits and audits of external suppliers. 

  • Execution of Environmental Qualification Protocols for a major orphan drug manufacturer as part of Consent Decree remediation.  Responsible for deviations, root cause analysis and CAPAs developed during the preparation, execution, analysis and final report for the project.  This involved working with multidisciplinary teams dealing with micro lab, maintenance, engineering, housekeeping, HVAC systems, BMS systems and manufacturing.  

  • Trained for execution of Trackwise system deviations, investigations and formal CAPA analysis.

  • QA remediation and oversight for SOPs and Protocols for regulatory compliance with 21 CFR, FDA, , EMA, TGA, WHO, USP and ISO requirements.

  • Analysis of API and product batching procedures of an Oral Solid Dose manufacturer to generate Quality System SOPs for oversight of production per 21 CFR 210 and 211 regulatory requirements.

  • Management of laboratory and supervision of quality control staff performing in vitro, in vivo and sterility testing of bacterial and viral vaccines regulated by USDA 9CFR, SAMs and FDA requirements.  This included hiring of appropriate staff, setting performance objectives, training on appropriate technique and SOPs, daily supervision and annual review.  

  • Sterilization process validation of production reactor demonstrating 106 reduction of spiked viral and mycoplasma contaminants.   

  • Review and approval of in-process and final product testing of viral and bacterial vaccines.

  • Review and final approval for QC release of in process materials and vaccines in SAP inventory management system.

  • Setup and supervision of vaccine stability and associated sample retention programs.  Reporting of results to upper management and as appropriate to the USDA.

  • Principle investigator for select agent lab.  Select agent testing and analysis in BSL-3 facilities.

  • Monoclonal and polyclonal antibody production, purification and application.

  • SDS-PAGE, Western Blot, protein concentration by densitometry and colorimetric assays, cell culture, ELISA, FACScan, viral titration and identity, PCR.

Relevant Work Experience

Quality Consultant/SME, July 2019 – November 2019, Confidential Client, NJ

Microbiology SME/Micro Director councilor for Micro Laboratory support to address FDA 483 and EIR/BLA deficiencies as part of voluntary third party oversight.

  • Advisor to Micro Director on strategy to address observations in regulatory communications.
  • Coordinate revision of and write SOPs for Micro Laboratory.
  • Write SOPs for Data Integrity Program for micro testing data of product, EM data for manufacturing and raw materials testing.
  • Write and oversee rewrite of EM annual and quarterly reports from previous and current year.
  • Review and rewrite of Production area EMPQ report.
  • Participate in EM program reconfiguration to be compliant with regulatory requirements.
  • Provide third party review of Microbiology Laboratory testing documentation.

 

Quality Consultant/SME, Feb 2019 – June 2019, Ultragenyx Pharmaceutical/Paragon Biosciences, Cambridge, MA

SME for Micro related deviations and investigations of third party CMO manufactured recombinant gene therapy products.  

  • Review of CMO generated deviations related to bioburden and EM deviations for correct analysis for root cause and regulatory expectation prior to review by external QP for regulatory approval.
  • Generation of protocols to identify sources of EM excursions and sources of bioburden.
  • Generate a product specific manufacturing sample plan for batch records covering preproduction to finished product.  

 

Quality Consultant/SME, Oct. 2018-Dec. 2018, ICU Medical, Austin, TX.

Microbiology SME for Quality review and approval of plant environmental quality records backlog.

  • Review and provide instruction for correction of documents.  Approval of reviewed documents and quality system records in MODA for 4 year backlog of records lacking quality approval.    
  • With one other consultant review and quality approve over 40000 individual tests in MODA system for Non-viable and viable particulates, RODAC plates, swab samples, product pre sterilization bioburden, and water system micro samples.

 

Quality Consultant/SME, The FDA Group, Aug. 2018-Sept.  2018, Beauty Manufacturing Solutions, Dallas, TX.

Microbiology SME for review of numerous microbiological issues cited in Warning Letter and 483s.

  • Provide comprehensive review of all Environmental, Water and Product microbiological citations in previous and current warning letters and 483s.
  • Write risk assessment for microbiological conditions of plant and water and provide comprehensive review of data for microbiological data for plant.  Identify deficiencies in previous submissions and describe actions to be taken.  

 

Quality Consultant/SME, March 2018-May 2018, Pharmedium, Memphis, TN

SME for Investigation Remediation project for a 503b compounding pharmacy in response to 483 citations.  Team Lead for Environmental Monitoring, Sterility and Endotoxin investigation backlog.

  • Assess investigation program for gaps with compliance of investigations scope and content.   
  • Define roadblocks to investigation process in all paper record system.
  • Identify methods to obtain and streamline information flow for investigation purposes.
  • Mentor company personnel assigned to investigations on investigation requirements and approach.
  • Review investigations performed by company personnel to identify deficiencies and define requirements for types of information required by investigations in different areas and circumstances.
  • Complete Rewrite of Corporate SOP for EM Investigations to align with regulatory recommended best practices and required scope of investigations.  

 

Quality Consultant, October 2017-Jan 2018, Lonza, Frederick, MD

SME / Project Manager for Clean Suite contamination detection and remediation project.  

  • Analysis of facility design and historical function review of performance for nine separate suites.  
  • Identification of areas of highest contamination levels and analysis of potential root cause(s).
  • Identification of root cause and determination of mitigation and CAPA activities.
  • Project management for execution of mitigation activities.
  • CAPA development for long term remediation plan.
  • Write Technical Investigation report for the project.

 

Quality Consultant, Feb 2017-Mar 2017, Celgene, Phoenix, AZ

Address MHRA audit observations for plant Environmental Monitoring program:

  • Write response to MHRA observation on environmental alert limits, changing limits to data driven levels.
  • Develop and write three protocols to generate data to address MHRA observation concerning lack of validation of media and incubation temperature for viable environmental monitoring plates.
  • Initiate retrospective review of environmental monitoring program SOPs, Validation procedure and historical data.

 

Quality Consultant, October 2016-Feb 2017, Xellia, Cleveland, OH

Laboratory Validation of Microbiological Assay and Laboratory Autoclave Validation: 

  • Verification of BET Assay (endotoxin gel clot) conformance to USP <85>.
  • Formal Training of Micro Laboratory staff on endotoxin assay
  • Write Validation Planning Document and URS for laboratory autoclave validation.  Assist with creation of engineer study of load patterns. 

 

Quality Consultant, July 2016-September 2016, Kedrion, Melville NY

In response to client commitments made in response to FDA 483s: 

  • Perform gap analyses of product bioburden assay methods and validation documentation in comparison with USP <61>, USP <62> and other regulatory requirements.
  • Perform investigation and document in an investigation report the gaps found between bioburden methods and validation documents vs USP and other regulatory requirements, identify and initiate CAPA remediation for each of the identified gaps.
  • Participate in investigations of mold contamination of production facilities and determine root causes. 

 

Quality Consultant, August 2015-December 2015, QuVa, Houston, TX.

  • Execution of due diligence audit for EM, Sterility and Endotoxin testing of a 503b compounding pharmacy subsequently purchased by the client.
  • On site audits of four separate nationally known sterility and endotoxin testing providers for compliance and service capability.
  • OOS sterility investigations, reports and CAPA determinations for products tested at third party testing facilities.
  • Endotoxin assay trouble shooting for inhibition or enhancement by substrate components.
  • Author of OOS investigations SOP in accordance with 21 CFR and USP guidance.

 

Quality Consultant, April 2015-June 2015, Acadia, La Jolla, CA.

  • Analysis of API and product batching procedures of an Oral Solid Dose manufacturer to generate Quality System SOPs for oversight of production per 21 CFR 210 and 211 regulatory requirements.
  • Working in a team of consultants developed Quality System SOPs for operation of a virtual company.
  • With the team generated and had approved by sponsor 36 SOPs and a total of 64 documents for Quality Assurance System oversight.

 

Quality Consultant, August 2014-April 2015, Teva, Greater St. Louis Area

  • Developmental study for confirmation of water quality of API manufacturer water system.  
  • Write Protocol, advise participants in sampling and testing and write final report.



Quality Consultant, June 2014-August 2014, Confidential South Korean IVIG Product Manufacturer

  • Review and provide comments on necessary changes in SOPs and validation protocols for Korean company prior to their submitting these to FDA as part of NDA for approval of use of their IVIG products in the US.  
  • Interact with clients on specific rationale and approach to submissions.



Quality Consultant, January 2014-May 2014, Genzyme, Boston, MA.

  • Review of all production records to analyze compliance with cGMP and FDA requirement for sampling and testing of products and drug and packaging compatibility for a major orphan drug manufacturer for remediation of findings under Consent Decree.  
  • Coordination with team members to meet time commitments and generate new versions of documents on schedule.

 

Quality Consultant, January 2013-September 2013, Genzyme, Boston, MA.

  • Execution of Environmental Qualification Protocol for remediation of findings under Consent Decree.  This included execution of five separate environmental qualification protocols for media, buffer, cell culture and purification areas in the production area.  A total of over 25,000 cumulative samples were collected for surface, viable air, particulate sampling.  Data was also collected for verification of HVAC pressure differentials, temperature and humidity.  Responsibilities included:
  • Supervision of technicians collecting samples over a five month sampling period.
  • Collection and review of data sheets for release of areas back to production
  • Writing protocol Non-conformances with required approval by third party oversight
  • Writing deviations for samples that were also current production sample sites
  • Executing deviations in corporate Trackwise deviation system.  Formal training by company for execution of all Trackwise system deviations.  
  • Responsible for determination of root cause of deviations and CAPAs required to address root cause and provide appropriate preventive actions to prevent similar deviations in the future.  
  • Execution and closure of the CAPAs required working with multidisciplinary teams dealing with micro laboratory, maintenance, engineering, housekeeping, HVAC systems, BMS systems and manufacturing.
  • Report preparation: Data review, graphing data verification, report review and logistical support.

 

Quality Consultant, October 2012-Janurary 2013, Luitpold, Long Island, NY.

  • Batch record and quality testing record retrospective review for company response to 483s for over 50 different parenteral products.  Scope of review included in process/raw material testing, packaging compatibility data for leachables and extractables, environmental monitoring tests, WFI testing, suitability tests for each product, final product testing, media fills and deviations/OOS/investigations.
  • Review of Sterility testing on specific batches and assessment of sterility test suitability compared to requirements of USP <71>.  
  • Review of Bacterial Endotoxin Testing (BET) for specific batches compared to the requirements of USP <85>.
  • Review of Particulate Matter Tests for specific batches compared to the requirements of USP <788>.  

Quality Consultant, April 2012-October 2012, MonoSol, Indiana

  • Writing /rewriting of Quality Control SOPs for a small pharmaceutical company to comply with FDA and EU regulations.
  • Creating training PowerPoint presentations for Quality System SOPs and performing training secessions for company personnel.  This included SOPs for Document management policy, Good Documentation Practices, Document creation and management, and record retention
  • Production Batch record auditing review and gap analysis.  Preparation of QA floor review checklist for batch record.
  • Contributions to a company-wide HACCP analysis focused on Microbiological risk to product.
  • Analysis of product microbiological testing and gap analysis against EU regulations for bacteriological testing.
  • Writing closure memos for CAPAs related to deviations in required micro testing of product.  
  • Review of qualifications for outside vendor for micro testing for company.
  • Team member for company effort to respond to FDA 483 citations and negative MHRA comments from audits.  Executed assigned tasks as part of team with timeframe limitations.
  • Writing CAPA descriptions in response to deviations noted in production and testing procedures.
  • Updating of Quality-Technical agreement with vender to comply with EU regulations for product provided.
  • Creation of SOP and associated vendor questionnaire on BSE/TSE product content and contact in accordance with EU regulations.
  • Writing investigation and closure memos for product complaints.
  • Contributed to writing sections of Annual Product Reviews (APR).  
  • With the Supervisor of Warehouse writing SOPs for the area compliant with FDA and EU requirements.
  • Oversight and coordination of update of Site Master File into EU format.  Obtaining information from subject matter experts and determination of needed information additions and updates needed.

 

Quality Control Supervisor, July 2004- May 2011, Intervet Inc./Schering Plough/Merck, Desoto, Kansas

  • Oversight of testing for two top vaccine products for the company.
  • Acting co-manager of quality control section for twelve month period in absence of manager.
  • Budget planning and review and allocation of QC resources to meet testing requirements in a cost-effective manner.
  • Supervision, review and approval of in-process and final product in vivo and in vitro testing of viral and bacterial vaccines.
  • Test reference monitoring and troubleshooting with members of R&D staff.
  • Responsible for the redesign of environmental monitoring (EM) program for new requirements.  This process required the complete rewriting of procedures, determination of meaningful monitoring sites, collection techniques and testing for viable and non-viable particles.  During this process alert and action levels were established for viable organisms for both the environment and personnel.  
  • Supervision of staff performing EM of sterile fill suite with review of results and follow-up on an ongoing basis.  
  • Supervision of personnel reviewing packaging component layout and color verification.
  • Oversight of quality input, testing, stability analysis and interaction with USDA for major product removed from the market due to vial to vial variation of potency.  Oversight of testing and data reporting as the product was redeveloped and stability tested to prove vial to vial variation was no longer a problem.  This resulted in a Shining Points Award of $500 dollars value for work related to getting this key product back on the market.
  • SOP and test method development, review, approval and implementation.
  • Review and investigation of out of specification (OOS) results, NOE and laboratory deviations, determination of appropriate CAPA. 
  • Contribute to gap assessments for comparison to company Global Quality Standards with corrective actions and follow up.
  • Annual review of outlines of production, special outlines, SOPs and test methods.  
  • Assist in audits by regulatory agencies, perform internal audits and audits of external suppliers. 
  • Sterilization process validation of production reactor demonstrating 106 reduction of spiked viral and mycoplasma contaminants.   
  • Review and final approval for QC release of in process materials and vaccines in SAP inventory management system.
  • Setup and supervision of vaccine stability and associated sample retention program.  Reporting of results to upper management and as appropriate to the USDA.
  • Principle investigator for select agent lab.  Select agent testing and analysis in BSL-3 facilities.



Staff Scientist/ Assistant Group Leader

Biotechnology Section, Life Sciences Division, 2000-March 2004

Midwest Research Institute, Kansas City, Missouri

Assistant Group Leader for the Virology and Immunology Group in the Biotechnology Section.  Two years experience overseeing in vivo and in vitro GLP studies of bacterial and viral vaccines.  Initial oversight of three simultaneous GLP regulated studies.  Over 2 years experience using BSL2/3 and ABSL3 facilities.  DNA cloning, expression, and analysis by Southern Blots.  Pathogen safety-trained in handling of National Institute of Allergy and Infectious Disease (NIAID) Category A-C priority pathogens.  Top secret clearance.

 

Technical Director, 1994-1999

Tissue Culture and Hybridoma Laboratory, Higuchi Bioscience Center, 

University of Kansas, Lawrence, Kansas

The responsibilities included facility oversight, maintenance, and facility budget.  Activities included generation of monoclonal/polyclonal antibodies to various antigens and  peptides; advising over 20 researchers at the university on  ELISA, monoclonal/polyclonal antibody production; development of ELISA to peptides based on amino acid sequence and related antigenicity; large-scale antibody production by ascites and bioreactor production (Technomouse); antibody purification by fluid phase liquid chromatography (FLPC); operation of Becton Dickinson flow cytometer (FACScan, a fluorescence-activated cell scanner)  for analysis of cell populations for specific cell surface proteins;  grant writing for the facility and in cooperation with other university researchers; project planning, scheduling.



Laboratory Manager, 1991-1994

Odontex Incorporated, Lawrence, Kansas

Managed a project for validation of an accelerated model of periodontal disease in dogs which was approved by the FDA.  The model was subsequently used for testing drugs for treatment of periodontal disease.  Responsibilities included: obtaining samples from dogs; isolation, cryostorage, and identification of over 4000 bacterial isolates using state-of-the-art anaerobic techniques such as Vitek-automated bacterial identification system; various fast strip ID methods and bench-top assays.



Education

M.A., Microbiology, University of Kansas, 1994

B.A., Biochemistry, University of Kansas, 1984

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