Sondra L. Fontenot
Quality Assurance
Longmont,CO
Summary
Results-driven Quality Specialist with over 20 years in Space, Biotech, and Medical Device sectors, including 12 years in Process Development and Quality Control. Expertise in developing quality management systems compliant with industry regulations and conducting audits to drive continuous improvement. Experienced in Root Cause Investigations and Technical Writing. Holds a BS in Microbiology.
Overview
24
24
years of professional experience
4
4
years of post-secondary education
Work History
Quality Assurance Specialist
Osypka Medtec Inc
Longmont, CO
04.2024 - Current
- Equipment Calibration/Maintenance Coordinator (GagePack)
- NCMR and CAPA Board Administrator
- Reviewed and approved change controls and deviations to ensure compliance with quality standards.
- Maintained comprehensive records for medical device regulations and quality assurance compliance.
- Facilitated the release of materials for the production environment.
- Calibration Certificates
- Processed purchase orders for equipment and supplies to ensure operational readiness.
- OOT Coordinator
Sr. Quality Assurance Associate
Luminex Corporation
Austin, TX
06.2018 - 04.2024
- Led QA for the ARIES Cassette Manufacturing Line.
- Led identification and support of complaint investigations for high-impact NCMRs related to field escapes
- Tracked high-impact NCMRs to ensure timely follow-up and completion of CAPA actions
- Assist with CAPA Investigations (CAPA Owner)
- Maintain compliance to cGMP, regulatory, and internal requirements for the manufacture and testing of Luminex products
- Reviewed and approved risk analysis, DHRs, and validation/verification protocols and reports to maintain compliance
- Support change control with input, review, and approval (SOPs, MIs)
- Participate in ISO, FDA, and Customer inspections or audits
- Proficient in working in the following databases in current role: Oracle, Oracle, Agile, Salesforce
- Maintained knowledge of medical device regulations and standards.
Title Abstractor
Land Group, TCO Land Services
Denver, CO
11.2017 - 04.2018
- Retrieved and organized contracts and documents from county website to support title abstracting process
- Documented and inputted data into in-house software system for efficient record-keeping
- Oil and Gas
Quality Assurance Specialist
XBiotech
Austin, TX
04.2015 - 05.2017
- Developed and approved SOPs, QC laboratory methods, and clinical manufacturing MIs to ensure compliance and quality standards.
- Reviewed and approved deviation investigations and CAPAs.
- Writing, review and approval of QC Investigations and NCs.
- Performed external audits of critical suppliers.
- Chosen by upper management to work on high-priority double-blind clinical trials. Labelled and shipped drug kits to USA sites while keeping contents (active ingredient vs. placebo) confidential even from the direct supervisor.
- Resolved issues between XBiotech Clinical Department and investigational site during clinical trial to maintain operational integrity and support trial objectives.
- Specialized in biopharmaceuticals and monoclonal antibodies.
Associate Scientist
Amgen
Longmont, CO
04.2006 - 12.2014
- Promoted to Associate Scientist from Sr. Associate (QC) in 2009.
- Delivered clinical and commercial support for product development, facilitating timely project advancement.
- Developed, remediated, and verified analytical methods for microbial detection and identification platforms, streamlining transfer into QC Groups.
- Oversaw quality-related tasks for P&PE NC program, ensuring compliance and operational efficiency.
- Chosen by upper management to assist the team in introducing the NC program to the Process and Product Engineering Group (P&PE).
- Led the P&PE Continuous Improvement Team
- Lead analyst: Management of daily activities for the P&PE DNA Group and Laboratory including equipment, testing schedules, performance metrics and report review and approval.
- Ensured all documents were in compliance with GMP or non-regulated SOPs
- Assisted QAs in auditing of P&PE SOPs
- Forensic analysis of Commercial Products using digital microscopy and FTIR methods
- Team member for Sub-visible characterization and Drug Product Investigations of Commercial products using Micro-Flow Imagining (MFI) and HIAC Liquid Particle Counter technology
Microbiologist III
EASI - NASA
Houston, TX
01.2002 - 01.2006
- Collected and processed environmental samples from NASA Centers, International Space Station, and Space Shuttle to support crew health initiatives.
- Identified bacterial and fungal isolates to support ongoing research using MicroSEQ Microbial Identification System and DNA Fingerprinting techniques.
- Executed classical microbiological techniques including culture isolation, gram staining, and biochemical testing in a BSL-2 laboratory.
- Conducted real-time PCR assays for detection of pathogenic organisms with RAPID portable detection systems.
- Trained laboratory personnel on molecular identification equipment and software maintenance, enhancing team proficiency and operational reliability.
- Established flow cytometry assays to analyze cellular activity.
- Ensured compliance with OSHA and VPP regulations throughout laboratory operations.
- Coordinated ISO 9001 documentation and control, ensuring compliance and standardization of laboratory procedures.
Education
Bachelor of Science - Microbiology
Louisiana State University
Baton Rouge, LA 08.1998 - 05.2002
Skills
- Quality assurance
- Regulatory compliance
- Process validation
- Validation protocols
- Nonconformance management
- Risk assessment
- Change management
- Equipment calibration
Training
- Process Validation Training for Medical Devices: Principles and Protocols, Oriel STAT A MATRIX
- ISO 14971:2019 Update Training, Oriel STAT A MATRIX, 2020
- Quality Risk Management Training, PDA, 2015
- Root Cause Analysis Training Program, Amgen, 2010
- Technical Writing, QI, 2010
Presentations
- Development and Qualification of MET-001347, Detection of Mycoplasma DNA in CHO Cell Culture using TaqMan Q-PCR, Sondra L. Fontenot, Christian Ryan, Mike Brewer, Tam Cartmell, Ph. D., Amgen Process Development Symposium (Internal), Longmont, CO, 2008
- Microbial Characterization and Comparison of Isolates During the MIR and ISS Missions, Sondra L. Fontenot, Victoria A. Castro, Virginia Bassinger, Rebekah Bruce, Mimi Healy, C. Mark Ott, Duane L. Pierson, 10th International Symposium of Microbial Ecology (Poster Session), Cancun, 2004
- A Survey of Staphylococcus species and Its Methicillin Resistance Aboard the International Space Station, Virginia Bassinger, Sondra Fontenot, Mimi Healy, C. Mark Ott, Duane L. Pierson, 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2004
- Stresses of Spaceflight and the Response of Monocytes to LPS, Indreshpal Kaur, Elizabeth R. Simons, Sondra L. Fontenot, Duane L. Pierson, 11th Annual Meeting of the PNIRS (PsychoNeuroImmunology Research Society), Titisee, Germany, 2004
- A Comprehensive Characterization of Microorganisms and Allergens in Spacecraft Environment, C. Mark Ott, Victoria A. Castro, Virginia J. Bassinger, Sondra L. Fontenot, Rebekah J. Bruce, Patricia Cruz, Linda D. Stetzenbach, Duane L. Pierson, NASA Bioastronautics Investigators Workshop, Galveston, Texas, 2005
- Recognition of Apoptotic/Necrotic DNA Isolated from AMG162 CP3 Production Culture by Q-PCR, Tina Smith, Christian Ryan, Bob Weaver, Sondra Fontenot, Leakhena Som, Tam Cartmell, Ph. D., Amgen Intern Presentations, Longmont, CO, 2008
- Recognition of Apoptotic/Necrotic DNA Isolated from AMG162 CP3 Production Culture by Q-PCR, Tina Smith, Bob Weaver, Christian Ryan, Leakhena Som, Sondra Fontenot, Tam Cartmell, Ph. D., Process Development Symposium, Longmont, CO, 2008
Timeline
Quality Assurance Specialist
Osypka Medtec Inc
04.2024 - Current
Sr. Quality Assurance Associate
Luminex Corporation
06.2018 - 04.2024
Title Abstractor
Land Group, TCO Land Services
11.2017 - 04.2018
Quality Assurance Specialist
XBiotech
04.2015 - 05.2017
Associate Scientist
Amgen
04.2006 - 12.2014
Microbiologist III
EASI - NASA
01.2002 - 01.2006
Bachelor of Science - Microbiology
Louisiana State University
08.1998 - 05.2002