Jessica Hessman
Kansas City,MO
Summary
A dedicated professional with a range of skills that encompasses multiple disciplines due to 15+ years of diagnostic laboratory experience and research opportunities from 8 laboratories, and 5+ years of total experience in the compliance and regulatory field, with 3 of those years as Compliance Manager. Attention to detail and problem solving are important factors in clinical settings along with being a vital part of implementing projects. In addition, it is vital to display critical thinking, independent judgement, and to organize information as it relates to ongoing and new research. Proficient in current industry regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Senior Associate Scientist II
Catalent Pharma Solutions
04.2021 - Current
- Serves as method lead on 7+ client projects for a range of techniques under cGMP, including cell-based bioassay, endotoxin, and rapid bioburden by coordinating analyst testing, reporting data appropriately, regular maintenance and review of documentation, and communicating progress/results to clients as needed.
- Participate in client calls by providing updates, presenting data, and troubleshooting to meet client needs, accommodate client requests and deliver results.
- Exhibits professionalism when dealing with client and Quality/Regulatory personnel.
- Understands federal and international regulatory requirements and guidelines related to client testing.
- Lead and participate in 6+ method development projects at different stages including feasibility, pre-qualification, qualification, and validation.
- Streamlined data management systems, resulting in improved accessibility and accuracy of critical information.
- Draft, author, and review technical documents including Methods, Protocols, SxP's, and Reports.
- Train analysts on instruments, technical skills, and methods while also providing guidance on cGMP documentation and professional development.
- Lead and participate in continuous improvement projects that will/has led to new capabilities for Catalent Kansas City, Biologics (implementation of bioburden detection via new rapid microbial methods) and improved lab organization and workflow (pipette stations).
- Selected to join the Tech Safe 3 committee to help the EH&S Operating System in relation to Contractor and Inspection/Audit programming.
- Goals include retaining company's ISO 14001/45001 and to enhance and add value to existing process.
- Followed strict safety protocols, protecting staff and assets while carrying out technical procedures and research protocols.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Maintained a safe working environment by adhering to best practices in laboratory safety procedures.
- Managed multiple projects simultaneously while maintaining strict deadlines and high-quality standards.
- Mentored junior analysts, fostering a collaborative work environment that facilitated skill development and growth.
- Established strong relationships with external partners, facilitating productive collaborations on joint research initiatives.
Compliance and Regulatory Consultant
Central States Testing LLC
05.2021 - 11.2023
- Provided guidance in veterinary biologics regulations for Central States Testing, LLC while navigating the licensing and permitting process through the USDA Center of Veterinary Biologics (CVB).
- Guided managers through all aspects of veterinary biologics regulatory issues and provided assistance with specific needs of the firm, including, but not limited to licensing, permitting, post-licensing regulatory issues, facilities review, mock inspections, and compliance post-licensing.
- Additionally, provided training, developed compliance plans, and helped resolve complex regulatory issues.
- Wrote or updated standard operating procedures, work instructions or policies.
- Conducted training sessions for client staff on relevant regulations and best practices to maintain ongoing compliance efforts.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Maintained and archived regulatory paperwork.
- Recommended improvements to processes.
- Prepared and submitted regulatory file applications and supporting documentation.
Compliance Manager
Central States Testing LLC
09.2018 - 04.2021
- Regular duties include establishing, setting, and reviewing standards for the companies Quality Assurance Manual and Standard Operating Procedures.
- Key components of regular duties include designing and updating internal policies to ensure that the Quality Management System is established, implemented, and maintained in accordance with ISO and CVB standards.
- Thus, mitigating company risk of breaking regulations set forth by the CVB and lead to internal audits of procedures or external inspection.
- Conceptualized and implemented a Risk Management system to minimize, monitor, and control the probability impact of unforeseen incidents from interrupting the company's production and manufacturing.
- Other responsibilities include managing the maintenance and distribution of the Quality Manual and associated documents, maintaining a master list of current versions of quality documents, training personnel on Quality Management System activities, monitors the Quality Management System, reports on the performance of the Quality Management System to senior management for review and as a basis for improvement of the Quality Management System
- Daily tasks involve maintaining records of all quality activities as documented in SOPs and methods
- Along with ensuring that all health and safety regulations, human rights legislation, OSHA, and federal guidelines are followed.
- Developed and delivered training programs to inform new and current employees about compliance issues.
- Streamlined compliance processes by implementing efficient monitoring systems and tools.
- Performed regular compliance reviews and audits, identifying non-compliance issues.
- Devised and maintained compliance recordkeeping processes to support initiatives.
- Established and monitored compliance procedures to provide consistent implementation across departments.
- Implemented effective compliance policies and procedures to meet regulatory requirements.
- Reviewed documents, files, transcripts, and other records to assess compliance and potential risk.
- Reduced risk exposure for the company by identifying and addressing areas of noncompliance.
Laboratory Client Services
Kansas State University College of Veterinary Medicine
06.2017 - 09.2018
- This position within KSVDL exists to serve the needs of clientele/stakeholders (clients, faculty, residents, students, coworkers) in regard to communication, sample reception, and sample processing
- This position was also involved in special projects dealing with client-oriented tasks pertaining to samples
- Primary tasks included working with clientele through phone, email, or direct contact and respond to their needs concerning test submission or resulting
- Performing this duty required a working knowledge of sample types, testing limitations, test availability, and the ability to evaluate the validity of consultation requests for KSVDL faculty
- Complaint inquiries and resolution were also an integral part of this position
- All of these tasks were expected to be completed in accordance with QA/QC procedures with the intent of adhering to AAVLD accreditation guidelines
- Additional duties included maintenance of multiple internal documents including but are not limited to SOP's, Working Instructions, referral submission forms, and electronically cataloging and sorting of current and passed submission forms.
Laboratory Research Assistant
Kansas State University College of Veterinary Medicine
08.2006 - 09.2018
- Diagnostic tests and Laboratory Techniques performed include Cell Culture, ELISA, Serum Neutralization, Hemagglutination Inhibition, IHC, Multiplex Assays, Flow Cytometry, Virus Sequencing, Gel Electrophoresis, Western Blot, DNA & RNA Purification & Isolation, Mass Spectrometry, AGID, IFA, PCR, and Virus Isolation on blood, feces, and tissue samples.
- Also collected serum and ear notch samples for different research purposes.
- Daily responsibilities included processing & prepping samples for diagnostic tests and correctly entering samples into a computer program.
- Able to recognize and problem solve technical, instrumental or physiological problems and offer solutions to the situation.
- Coordinated and managed laboratory projects and experiments.
- Managed inventory of lab supplies, ensuring all necessary materials were readily available for experiments.
- Prepared reagents and solutions following standard laboratory formulas and procedures.
- Operated and performed preventative maintenance on laboratory equipment and instruments.
- Supported project leads in grant applications by presenting detailed preliminary data demonstrating feasibility of proposed studies.
- Conducted thorough literature reviews to support hypothesis development and inform experimental design decisions.
Research Laboratory Technician
Central States Testing LLC
06.2004 - 08.2006
- Hired by Dr. William Hessman to test cattle samples for a research project.
- Daily responsibilities included correctly processing samples that arrived in from feedyards, entering samples into the computer, and testing the samples via ELISA.
- Attention to detail and problem solving were critical parts of the job since it was for a research project.
- Detailed results were sent out to the feedlot and were able to isolate infected animals in a timely manner.
- Other responsibilities included creating Standard Operating Procedures and test guidelines that were used in the laboratory on a daily basis.
- Trained new laboratory technicians on proper techniques, guidelines, and equipment usage, ensuring a consistent level of quality across the team.
Education
Minor, Biology, General -
Kansas State University
Manhattan, KS01.2011
Took 70 hours of upper level public health/biomedical sciences classes for a couple of years. -
Kansas State University
Manhattan, KSBachelor of Science, Animal Sciences -
Kansas State University
Manhattan, KS01.2011
Skills
- Good Management Practice (GMP)
- Project Management
- Data Analysis
- Analytical Skills
- Team Building
- Leadership
- Laboratory Skills
- Regulatory Compliance
- Time Management
- Peer Reviews
- Laboratory Management
Certification
- Lean Six Sigma White Belt Certification - Catalent Pharma Solutions
- NAHLN - USDA
- Quality Management Systems Course
Awards
- Customer Dedication - Catalent Pharma Solutions, 05/2023, An honor bestowed for showing unparalleled customer dedication by coordinating teamwork and executing a project for a client.
- Patient First Award - Catalent Pharma Solutions, 06/2023, awarded the Patient First award on behalf of the BioAnalytics Leadership Team for demonstrating the BAS Values Award for Customer Dedication. This award was bestowed due to consistently helping to produce excellent results for a commercial molecule program with a client by leading and organizing activities within my department. A large amount of work comes from this client to test stability and release samples with a difficult bioassay as well as perform extensive protocols required for reference standard and control sample qualification, generate analytical cell banks, and perform functional testing of the cell banks.
Timeline
Compliance and Regulatory Consultant
Central States Testing LLC
05.2021 - 11.2023
Senior Associate Scientist II
Catalent Pharma Solutions
04.2021 - Current
Compliance Manager
Central States Testing LLC
09.2018 - 04.2021
Laboratory Client Services
Kansas State University College of Veterinary Medicine
06.2017 - 09.2018
Laboratory Research Assistant
Kansas State University College of Veterinary Medicine
08.2006 - 09.2018
Research Laboratory Technician
Central States Testing LLC
06.2004 - 08.2006
Minor, Biology, General -
Kansas State University
Took 70 hours of upper level public health/biomedical sciences classes for a couple of years. -
Kansas State University
Bachelor of Science, Animal Sciences -
Kansas State University