•Interprets and adheres to related regulations (e.g., Global ERES regulations, EU directives, GxPs)• Oversees and manages the validation process for RTSM general releases, ensuring all requirements are met and that the highest quality standards are upheld• Develops and implements new validation techniques and procedures• Defined an enhanced CSV strategy for the RTSM product line• Provides technical guidance and coordinates and collaborates with team members to ensure validation deliverables are produced, executed, and documented appropriately• Provides support during customer audit inquiries• Creates and reviews requirements for testability• Performs risk assessments• Manages testing and test incident process to closure• Supports change management process for product(s) or internal business systems

• Directs, supervises, and evaluates work activities of medical personnel• Implements organizational policies and procedures for the medical unit• Performs diagnostic tests such as electrocardiograms, pulmonary function tests, laboratory tests and administers required immunizations.• Performs quality control and calibrates equipment as necessary• Initiates baseline medical records and performs record reviews to ensure personnel are ready to fulfill the physical and mental requirements of their position

•Performed Computer System Validation (CSV) audit activities including planning, conducting, reporting, follow up and support, corrective action and preventative action (CAPA) reviews, and approvals determination.• Participated in the creation and maintenance of the risk-based computerized systems audit planning by gathering data and calculating associated audit entity risk factors.• Addressed areas of risk identified from individual audits and lessons learned that could be leveraged globally to assist in corporate risk reduction and inspection readiness.• Supported the development and maintenance of audit-related SOPs and tools.• Collaborated with internal teams to cross-train on computerized systems validation and audit foundational understanding.• Assisted in scheduling and responding to sponsor audit requests, findings/observations through closure.• Supported development of preventive actions for audit-related findings, tracked and reported updates through closure internally and to clients.• Captured and analyzed metrics from the audit program for sponsors, vendors and internal audits to propose efficiencies and continuous improvements.

•Reviewed and analyzed software validation documentation located within the EDMS to ensure accuracy.• Applied knowledge of the Software Development Life Cycle and Change Control Process to ensure project compliance with all company procedures; identify occurrences of deviation from SOPs and Work Instructions.• Provided authorization for system releases into Development, Validation, UAT and Production environments.• Advised project delivery team regarding applicable SOPs, GDP and 21 CFR Part 11 compliant execution of software validation documentation.• Supported the review, update, filing and distribution of controlled documents.• Researched and reviewed software defects within JIRA and Azure DevOps to ensure accurate reporting.• Composed content in Deviation Forms and Notes-to-File.• Identified and compiled Quality and Compliance metrics.• Conducted internal audits and reported findings and nonconformances to the Audit Manager.

• Provided training to Medical Assistants using a mixture of classroom instruction and on-the-job training• Supervised, trained and created duty schedules for 26 members resulting in 108K established medical appointments• Tracked projects and performed quality assurance on programmatic documentation• Performed administrative office support functions and maintained cooperative working relationships with team members, related functions and operating officials• Scheduled and coordinated meetings as well as travel arrangements for office staff• Composed and oversaw appointment templates and schedules for nine providers increasing access to healthcare for 4,500 enrollees• Reviewed Air Force policies, regulations, and job descriptions annually for revisions and applied updates to subordinates and to the daily operations of clinic• Inventoried, procured and maintained 371 items of medical supplies and equipment, and executed $168,000 budget for three clinics resulting in uninterrupted services to base population• Created documents such as correspondence, drafts, memos and emails as well as recorded, transcribed, and distributed meeting minutes• Responsible for ensuring that the medical credentials of offsite medical providers were up to date and scheduling training for these providers as needed in order to minimize a delay in daily operations• Proficient in facility monitoring and implementation of OSHA safety guidelines by managing 64 employee safety records and overhauling training plan• Prepared and administered medications as directed by a physician• Recorded patients' medical history, vital statistics, and other pertinent information such as test results in medical records• Interviewed patients to obtain medical information and measure their vital signs, weight, and height• Operated equipment such as pulmonary function tests (PFTs), external defibrillators, and bag valve mask resuscitators in basic and advanced life support environments

• Provided resiliency training to strengthen the mental, physical and spiritual health of staff and their family members by evaluating, updating and administering curriculum in a classroom setting• Reviewed Air Force policies, regulations, and job descriptions annually for revisions and applied updates to subordinates and to the daily operations of clinic• Improved well-child care by validating and vaccinating over 1,500 children in one year which led to the clinic being ranked second out of 75 Military Treatment Facilities in the Air Force• Averted $36k of $1.4M budget by training and coordinating activities for 12 medics• Maintained computerized record management systems to store and process data, such as personnel activities and information, and to produce reports• Conducted and administered fiscal operations, including accounting, executing budgets, and coordinating financial reporting• Planned, implemented and administered programs and services in a health care or medical facility, including personnel administration, training, and coordination of medical, and nursing staff• Enhanced public relations, coordinate activities and plans, and promote health programs• Performed diagnostic tests such as skin pricks, intradermal, patch, and delayed hypersensitivity tests​• Administered allergy serums, immunizations and emergency drugs under a physician's direction.• Preformed 10-fold dilutions