Chelsey Hinkle

Owning continued education for HIPAA and OSHA trainings companywide through MediaLab and tracking using MasterControl as our eQMS

• Implementation of trainings plans companywide with each department in MasterControl for controlled training plan for everyone and management to be able to track electronically
• Leading efforts in MLR (medical, legal, and regulatory) meetings throughout the company on marketing documents, social media posts, and press releases
• Sysadmin role in MasterControl which includes but is not limited to adding accounts, resolving account issues, and assigning roles based on department heads requests
• Continual implementation of Equipment, Supplier, BOM, Audit, Quality Events modules for the CLIA and R&D department in MasterControl.
• Leading project management for MasterControl implantation with primary contacts to keep schedule on task for MasterControl and Oncocyte
• Leading project Supplier Management Team in GxP vendors companywide, with implementing forms required in MasterControl, and weekly reviews sessions conducted for review of each GxP vendor before approvals.
• Owning the role of Management Review coordinator for the quarterly management reviews that help keep the company in compliance for CLIA, CAP, ISO regulations for the CLIA and R&D lab within Operations
• Supporting the Director of Regulatory in FDA Breakthrough submission efforts for responses and oversight
• Monitored changes in legislation, adjusting company policies accordingly to maintain compliance standards within eQMS standards for CAP, COM.001200, GEN. 43033, 42 CFR 493 21 CFR 820, ISO/ IEC 15459, Chapter I IVDR (2017/746), Chapter II EU-IVDR (2017/746), OSHA, ISO 13485, ISO/TS 20914:2019..
• Performed and documented quality control checks to maintain compliance with company initiatives.

• HIPAA and OSHA training specialist for sites in Irvine, Nashville, and Germany in the training system MediaLab
• Successfully completed implementation of Documents and Training module in MasterControl with standards built in for CAP, COM.001200, GEN. 43033, 42 CFR 493 21 CFR 820, ISO/ IEC 15459, Chapter I IVDR (2017/746), Chapter II EU-IVDR (2017/746), OSHA, ISO 13485, ISO/TS 20914:2019.
• MasterControl training included training colleagues on use of the system (logging in, creating and obsoleting of documents, developing create, view, and MLR workflows and work instructions)
• Leading implementation of training plans companywide in MasterControl with department managers.
• System admin role in MasterControl which includes but is not limited to adding accounts, resolving account issues, and assigning roles based on department heads requests
• Coordinating efforts in the configuration and implementation efforts of the Nonconformance and Equipment modules in MasterControl
• Leading efforts for supplier qualifications for GxP and Non-GxP vendors companywide
• Coordinating updates and communications for quality/regulatory systems including MasterControl, MediaLab, and TechStreet
• Assist in maintaining compliance with quality and regulatory requirements
• Collaborated with cross-functional teams to develop robust processes, ensuring compliance with industry standards.
• Provided training on quality systems procedures, fostering a culture of continuous improvement within the organization.

• HIPAA and OSHA training specialist for sites in Irvine, Nashville, and Germany in the document control systems of DocBase and MediaLab
• Enhanced employee performance by developing and implementing comprehensive training programs.
• Coordination of onsite training for Irvine and Nashville locations
• Implementation of MasterControl platform for 'Go Live' in Training & Documents companywide
• Building of Supplier Management Process for new vendors
• Evaluating risk levels, vendor certifications, and agreements before qualifying a supplier for usage
• Collaborating and building along with Sr
• Manager the Commercial Operations & Marketing Communications in implementation of medical, legal, and regulatory (MLR) process
• Transferring from a manual numbering system to MasterControl auto-numbering system
• Assist the Quality department in completing the New York State Department of Health (NYSDOH) audit and CAP audit for products in the Irvine location
• Acted as Interim lead for medical, legal, and regulatory (MLR) process which involved review and release of new documents for publication

• Assumed Interim Director of Regulatory, providing regulatory feedback for products wanting to be pushed to FDA, New York State Department of Health
• Continued conversations with CORE team members and external consultants for each product on what actions were required for regulatory backing
• Ensured products met the company’s and patients’ regulatory needs
• Proven ability to learn quickly and adapt to new situations.

• Primary contact in the Quality & Regulatory Department for any internal/external needs to ensure a smooth transition throughout the day
• Assisted directors with various day-to-day tasks such as calendar management and correspondence handling.

• Training coordinator for HIPAA and OSHA training requirements for Irvine, Nashville, and Germany sites
• Uploading documents for approvals and reviews in the company's eQMS, DocBase
• Ensuring new employees’ information is uploaded into DocBase and MediaLab for required training
• Working closely with departments on formatting documents before release, handling brainstorming sessions for training, and addressing specific needs from all staff members
• Working closely with department managers for new hire training and plans for onboarding, on-site training, and offboarding requirements
• Evaluated current document processes, suggested methods for change and implemented successful improvements.
• Management Review hand-off for preparation and success of quarterly meetings to meet requirements for ISO 9001.

• Worked customer due diligence as third party for Wells Fargo on LLCs, LP’s and new accounts opening
• Led the team in collection of documents and using checks and balances to ensure accuracy before allowing loans to be opened or continued
• New and existing employee point of contact for training on document control system utilized per Wells Fargo's new loan guidelines
• Department lead for 1:1 meetings weekly and group meetings held every other week
• Primary contact for further training within the company to enhance knowledge for Wells Fargo's new loan setup to bring back, and train QC loan department
• Oversaw Quality Control Managers calendar for day-to-day or 1:1 meeting with team members
• Managed managers’ emails in their absence, and team meetings as backup to keep everyday operations continuous

• Handled day-to-day reception duties, helping escrow officers prepare closing documents and sending packages that needed to be made and mailed or scanned and faxed—supporting close escrow CDs before closing having checks and balances on purchases, and sending packets out once completed
• Certified notary in Texas; if travel notaries were unavailable to make a closing
• Ordered supplies when running low and ensured the office space operated to its fullest potential daily.
• Supported team members in managing their workload, contributing to more productive work environment.

• Managed field managers in collecting of documentation, scheduling and certification of completed work
• Handled daily office activities and meeting preparation
• Point of contact for updating workers' compensation certificates, bonding needs, bid updates required before new job starts
• Connecting with school districts and project managers on receiving job plans (blueprints) before starting or bidding on new construction or modifications
• Point of contact for collecting required documents for background and fingerprinting, and checks for new employees, collecting I9 records before start date
• Managed CFO's daily meetings, appointments, and calendar
• Heavy calendaring for CEO and CFO for professional and personal matters.

• Managed paper and electronic filing systems by routing various documents, taking messages and managing incoming and outgoing mail.
• Scheduling appointments, order supplies, and collected payments from clients not covered by their insurance
• Contacted insurance for verification of coverage