QUALIFICATIONS

Jennifer Asleson Muncy headshot with a black circle

Jennifer R. Asleson

Jennifer has over 25 years of experience in the regulated pharmaceutical and medical device industries. In addition to extensive knowledge of ISO 13485 and ISO 9001, Jennifer has considerable experience with the implementation and continued compliance of numerous AAMI Standards including:

  • AAMI/ISO 11135
  • AAMI/ISO 11137
  • AAMI/ISO 11737
  • AAMI/ISO 17665
  • ISO 14644

Jennifer gained valuable insights into the manufacturing and utilization of biological indicators as well as process challenge devices during her years at SGM Biotech. Her recent time as a microbiology technical expert for BSI provides insights from the Notified Body perspective for all classes of medical devices.

When not working, Jennifer performs with several local symphony orchestras and follows Major League Baseball. She enjoys her working in her greenhouse and exploring this wonderful country’s public lands and parks, with an emphasis in paleontology.

EDUCATION

BACHELORS DEGREE – BIOLOGICAL SCIENCES
University of California, Davis

MINOR – MUSIC PERFORMANCE
University of California, Davis

University of California Davis badge

Certifications

ASQ CPGP : Certified Pharmaceutical Good Manufacturing Practices Professional

Current Good Manufacturing Practices Professional (ASQ)
Awarded May 2009

Biomedical Auditor (ASQ)
Awarded October 2011

Courses

  • Implementing and Auditing an ISO 9000:2000 Quality System, ASQ
  • Internal Auditing Training for ISO 13485, Stat-A-Matrix
  • Risk Management for Medical Device Businesses, Processes and Products, ASQ.
  • Exam Writing Workshop, ASQ
  • Irving Pflug’s Microbiology and Engineering of Sterilization Processes
  • Training on the Canadian Medical Devices Conformity Assessment
  • System (CMDCAS) Accademia Qualitas, Inc.
  • CE Marking of Medical Devices BSI

Affiliations

  • Senior Member, American Society for Quality (ASQ)
  • Author/reviewer CPGP Handbook (ASQ)
  • AAMI Working Groups for EO, Radiation, Moist Heat, Microbiology
  • Methods, and Biological Indicators
  • Major contributor AAMI TIR 52
  • Contributor AAMI Sterilization Specialist Certification Exam
  • Geological Society of America (GSA)
  • Society of Vertebrate Paleontology (SVP)

Professional Profile

Medical Device

Technical Expert – Microbiologist  |  BSI Americas

  • Plan, execute and prepare reports for microbiology and sterilization audits as part of Notified Body certification to various Standards and Regulatory Requirements.
  • Participate in Certification assessments to ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2016, ISO 9001:2005, ISO 9001:2015.

Sterilization Quality Engineer |  W.L. Gore

  • Commercialized product support for sterilization.
  • Driving sterilization related CAPAs and NCRs to completion in a timely manner.
  • Planning and performing sterilization supplier audits as well as resolving quality issues with sterilization suppliers.
  • Conducting annual re-qualifications for current commercialized cycles.
  • Writing procedures and training and assisting technical associates.
  • Develop and maintain quality metrics for sterilization vendors.
  • Maintaining trending of microbiological data related to sterilization activities.
  • Lead auditor for internal audit program and supplier quality.
  • Gap Analysis of ISO 11135:2014.
  • Support AAMI Working Groups for microbiology and sterilization.

Plant Quality Leader  |  W.L. Gore

  • Lead all aspects of Quality Systems at facility.
  • Successfully prepare for and lead Notified Body Inspections.
  • Support manufacturing and sterilization activities.
  • Drive NCRs and CAPAs to completion in a timely and compliant manner.
  • Review complaints and provide supporting data as needed.
  • Ensure new and revised documents meet the quality system requirements.
  • Develop, maintain, and report quality metrics.
  • Lead auditor for internal audit program.

Microbiologist/Biological Indicator Specialist  |  Becton Dickinson

  • Develop and implement Corporate Policies and Procedures for microbiology, controlled environments and sterilization.
  • Revitalize existing Biological Indicator Program to bring current with industry standards.
  • Present quarterly and annual reports on sterilization/microbiology excursions across BD to Global Director of Sterilization Services.
  • Plan, execute and participate in audits of vendors.
  • BD Subject Matter Expert (SME) on biological indicators.
  • Sterility Assurance Leadership Team (SALT).
  • Provide technical support to lab leaders across BD worldwide.
  • Participate on AAMI working groups.
  • Project manager for development and implementation of new sterilization processes and development of new external process challenge device.

Microbiologist/Sterilization Coordinator  |  Becton Dickinson Medical, Pharm Systems

  • Oversee microbiology, sterilization and chemistry laboratories.
  • Leader in validation activities for ethylene oxide sterilization, both new chambers and existing processes.
  • Perform supplier quality audits.
  • Lead customer, quality, and Notified Body audits/inspections.
  • BD Subject Matter Expert (SME) on biological indicators.
  • Interact with manufacturing to maintain controlled environments.
  • Establish and bring into compliance new Chemistry Laboratory.
  • Oversee chemistry testing including ICP-MS, GC and FT-IR.

Quality Assurance Manager  |  SGM Biotech Inc.

  • Oversee Quality System requirements for Medical Device company.
  • Enhanced existing Quality System to better meet CFR 820.
  • Manage all customer, quality, and regulatory audits.
  • Maintain CAPA, MDR and Customer Complaint process.
  • Established new SOPs and Quality Manual.
  • Management Representative responsibilities.
  • Final release of all products.
  • Participate in Design and 510K processes.
  • Prepared for and successfully achieved certification for ISO 9001 and 13485.
Pharmaceuticals

Supervisor | Purification Department  |  Chiron Corporation

  • Supervised staff and was responsible for the final formulation step in the manufacture of various parenteral drug products (protein purification).
  • Reviewed and approved all production records.
  • Developed and implemented new training and documentation practices.
  • Participated in quality and regulatory audits.
  • Guided team to reduce documentation errors in production records.

Supervisor | Special Studies Laboratory  |  Chiron Corporation

  • Supervised staff for microbiological assays such as product sterility testing and PET.
  • Ensured compliance to all USP and company requirements.
  • Supported regulatory audits of microbiology laboratory.

Microbiology Tech IV  |  Microbiology Laboratory  |  Dey Labs

  • Perform microbial identification.
  • Read and interpret results from environmental monitoring, bioburden and USP product sterility.
  • Initiate, investigate and complete investigations for excursions or adverse trends.
  • Support Microbiology Techs in performing various assays.
  • Perform growth promotion, bacteriostasis/fungistasis and other assays as required.
  • Review and approve production run records for release of product.

Microbiology Tech III  |  Microbiology Laboratory  |  Dey Labs

  • Perform bioburden, product sterility and LAL testing of pharmaceutical products
  • Assist Microbiology Techs in environmental monitoring and sample collection
  • Formulate growth media and other reagents as needed.
  • Run laboratory autoclave and other equipment.