Jeff Voors
Upland, Indiana
Summary
Highly accomplished and results-oriented Senior Quality Assurance Representative with over 20 years of experience in pharmaceutical and animal health industries. Proven expertise in GxP compliance, quality oversight for R&D and manufacturing, and laboratory operations. Adept at fostering cross-functional partnerships, driving compliance initiatives, and ensuring product quality and safety from development through commercialization.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Sr. Representative - Quality Assurance
Elanco Animal Health
01.2013 - Current
- Provide comprehensive quality oversight for animal health development activities, supporting both site-specific and global projects.
- Partner with business units to ensure compliance with Elanco's internal requirements and applicable regulatory authorities.
- Cultivate strong collaborations with Elanco R&D teams, offering expert consultation on quality-related matters.
- Proactively enhance compliance through the implementation and monitoring of Elanco Global Quality Standards, training programs, and compliance tools.
- Manage deviation and change control processes for project and site activities, ensuring successful CAPA and change action implementation.
- Participate in the creation and revision of Quality standards and support the rollout of quality processes across the site.
- Assist with regulatory inspection preparations, ensuring site inspection readiness.
- Deliver quality and compliance training to R&D personnel.
- Plan and conduct GxP oversight activities, including GRP, GCP, and GLP study reviews/audits, site self-inspections, and qualification/oversight of third-party work.
- Issue inspection reports and review/approve responses and corrective actions, demonstrating proficiency in GCP.
- Execute release of investigational batches (drug substance/API, drug product, vaccines), seed and cell lines, and other development materials per Elanco R&D Quality System requirements.
- Act as Computer Systems Quality Assurance (CSQA) representative for associated projects and site activities.
Microbiologist
Elanco Animal Health
01.2011 - 01.2013
- Collaborated with technology partners on the design and development of vaccines for companion and food animals.
- Executed mammalian cell culture and cell banking activities critical for animal vaccine development.
- Authored and implemented protocols for cell banking and conducted optimization studies for cell culture processes.
- Developed study protocols and reports for proof-of-concept and challenge model studies to evaluate vaccine efficacy.
- Monitored clinical studies, ensuring CRO personnel and facilities met qualification standards and study activities adhered to protocols.
- Partnered with Elanco Regulatory and Quality Assurance to ensure compliance with 9 CFR regulations and Elanco policies during study execution.
Microbiologist
Volt Services Group at Elanco Animal Health
01.2010 - 01.2011
- Played a key role in establishing a new laboratory dedicated to animal vaccine development.
- Managed lab supplies and equipment, ensuring operational readiness.
- Coordinated the acquisition of essential equipment, including bioreactors for vaccine production and a lyophilizer for vaccine preparation.
- Performed mammalian cell culture for animal vaccine development and drafted cell banking protocols.
- Conducted cell culture optimization studies and performed virus titrations (TCID50 and hemagglutination assay) for animal virus quantification.
- Designed and implemented a study protocol to identify optimal serum-free media for culturing adherent MDCK cells.
- Coordinated the transfer of viral and bacterin seed and cell reagent stocks from Pfizer Animal Health post-acquisition.
R&D Scientist
Thermo Fisher Scientific
01.2004 - 01.2009
- Designed experimental methods to advance in-vitro diagnostic immunoassays from proof-of-concept to 510k submission.
- Formulated assay reagents and components, analyzed data, and documented/interpreted results.
- Prepared comprehensive protocols, technical reports, and data summaries.
- Improved assay performance by optimizing conjugate load on microparticles, resulting in reduced lot-to-lot variability and increased reagent stability.
- Developed an immunoassay for monitoring immunosuppressive therapy in transplant patients, achieving FDA clearance for blood-level testing.
Education
Bachelor of Science (B.S.) - Biology
Purdue University at Fort Wayne
Fort Wayne, INSkills
- Analytical Method Development and Validation
- Auditing
- Cell Banking
- Change Control
- Computer Systems Quality Assurance
- CRO Relationship Management
- Deviation Management
- Analytical Equipment IQ/OQ/PQ
- Good Clinical Practice (GCP)
- Good Documentation Practices
- Good Manufacturing Practice (GMP)
- QA Batch Release
- Quality Assurance
- Protocol Writing and Data Analysis
- Project management
- Relationship building
- SOP Writing
- Vaccine Development
Certification
- NGF-KSU HACCP For the Feed Industry; IGP Institute-Kansas State University; September 2017
- FSPCA Preventive Controls for Animal Food; Food Safety Preventive Controls Alliance-Kansas State University; September 2017
- Corporate Introduction to GMPs; Eli Lilly Corporate Learning Center; February 2014
- Basic Veterinary Immunology and Principles of Vaccination-Veterinary Biologics Training Program; Institute for International Cooperation in Animal Biologics; College of Veterinary Medicine, Iowa State University, Ames, IA; May 2013
- A New QMS Immunoassay for the Quantitative Determination of Everolimus in Whole Blood; Alex Shvets, Jared Boyd, Jeff Voors, Mary Cox and Lili Arabshahi. Presented at American Association for Clinical Chemistry (AACC) 2006 Conference in Chicago, Ill.
- Adenoviral Vectors as Agents of Gene Transfer to Promote Neuronal Cell Growth, Senior Seminar at Purdue University, 1999
Timeline
Sr. Representative - Quality Assurance
Elanco Animal Health
01.2013 - Current
Microbiologist
Elanco Animal Health
01.2011 - 01.2013
Microbiologist
Volt Services Group at Elanco Animal Health
01.2010 - 01.2011
R&D Scientist
Thermo Fisher Scientific
01.2004 - 01.2009
Bachelor of Science (B.S.) - Biology
Purdue University at Fort Wayne