Stacey Hernandez

• Develop and execute site wide GMP gap analysis on over 100 validated computer systems used to manufacture pharmaceutical products
• Develop and document all processes used in GxP IT Systems management and support
• Lead GxP computer systems’ implementations collaborating with scientists, vendors, QA and validation
• Develop and implement data integrity strategies including data protection, backups and disaster recovery
• Maintain systems under change control and assist with impact assessments and necessary documentation for changes
• Generate and maintain Standard Operating Procedures (SOPs) and system description documents
• Collaborate with corporate IT team to support infrastructure needs for GxP systems
• Demonstrate excellent interpersonal skills, including the ability to resolve conflicts using poise, diplomacy and tact and the ability to interact with people of a wide variety of backgrounds, levels of responsibility and education levels
• Drafted change management policies to streamline introductions of new software and systems
• Designed company-wide backup and data retention policies, monitoring ongoing efforts to prevent data loss
• Led company-wide system installation, overseeing upgrades to provide minimal interruptions to business continuity
• Administered system controls, databases and networks
• Created and maintained policy documentation on troubleshooting systems, detailing best practices and inherent goals

• Collaborate with line functions and validation departments to represent Quality Assurance and complete validation activities pertaining to planning, installation, qualification, release for use, and retirement.
• Serve as System Administrator for all Validated Computer Systems on Site Work cooperatively with system owners to ensure CSV compliance, timely and appropriate audit trail reviews, and access and user control.
• Lead support site Data Integrity program, QA review and approval of Equipment and System Validations that have a CSV element. Review and approve SOPs, work instructions and templates. Review and approve validation protocols and final reports, and ensure that validation documentation is adequate, correct, and controlled appropriately.
• Perform risk assessments for computerized systems/applications and provide input regarding compliance requirements for GxP systems.
• Effectively communicate validation requirements to affected departments within the organization and ensuring that validation is performed in a cGMP compliant manner.

• Utilizes automated testing tools to build and execute tests
• Coordinates with business teams, development teams and vendors to determine testing and test automation coding requirements
• Designs, codes, and tests, test automation components for complex or cross-functional systems, sub-systems or other technical solutions
• Identifies multiple solutions and determines best approach to solve complex test automation opportunities with systems and software
• Accountable for on-time completion of tasks
• Demonstrates expertise and knowledge in multiple areas of technology & actuarial sciences
• Analyze data and further related analysis
• Work with engineers for advanced algorithm/functionality development
• Diagnose and report incorrect results

• Integration/Stability/System testing along with smoke checking of new SW/FW/HW builds for a Class II Medical Device
• Assisted in the completion of Validation & Verification of Class II medical device per FDA guidelines ahead of projected completion date.
• Created and executed complex test protocols for Class II medical device per FDA guidelines for an IVD product by distilling software and UI requirements, considering product design documentation and risk mitigation plan.
• Worked with software developers, hardware and system engineers with regard to project plans, defects, product improvements, user operations and requirements specifications.
• Write, review and execute manual complex test plans from software development and customer requirements .
• Troubleshoots product, project problems, improvements and field complaints discrepancies.
• Develop instructions and documentation of SW manuals, V&V validation plans, acceptance criteria documents and project plans.
• Perform hardware integration to upgrade systems by improving the accessories, design, and speed of systems to increase efficiency.

• Responsible for the creation and maintenance of over 580 client verification websites.
• Assisted in bringing client trouble ticket numbers down significantly by creating message templates used by entire support team.
• Responsible for first response in answering, commenting and replying to open incidents in the Client Incident Queue.
• Ability to prioritize tickets according to priority and delegate tickets to team members.
• Strong aptitude in application navigation. Repairs, Spyware removal, virus removal, hardware, troubleshoot upgrades. Update and maintain company contacts.
• Collaborated with business owners, vendors and other team members to evaluate and recommend solutions to complex problems and requests.
• Documented clients' issues and processes of resolution.
• Supported daily operations and system maintenance procedures.

• Performed log analysis on over 15 local servers, as well as 50 remote servers.
• Corrected errors on client claims submitted remotely through servers.
• Correct errors on client claims submitted remotely through servers.
• Communicate with Development teams regarding bugs or defects. Coordinate the tracking and submittal of outstanding transactions and claims with over twenty clients. Run daily reports for the tracking of medical claims using company software.
• Tools/Applications: SecureSRT, Filezilla, EditPlus3, Microsoft Office
• Coordinated engineering assignments for multiple simultaneous projects to fulfill prescribed project requirements.
• Collaborated with cross-functional teams to develop and implement process changes.

• Performed and supervised black box testing for client application software (DLE, HMSS) for medical devices.
• Use in-house Pump Simulator application as a Client server to execute Auto-Programming testing on medical infusers.
• Perform log analysis on client application software log files and SQL database.
• Perform Software Quality Assurance on software and computer applications designed for the medical industry. Perform Black-Box testing on client applications and web based software.
• Wrote and optimized test cases to maximize success of manual software testing with consistent, thorough approaches.
• Optimized test cases to maximize success of manual software testing.
• Conducted regression testing, analyzed results, and submitted observations to development team.
• Conducted regression testing and submitted observations to development team.
• Designed testing scenarios for usability testing.

• Successfully assisted in the launching of over 15 satellites and spacecrafts into orbit.
• Installed and maintained over 50 complex flight operation servers used in daily operation of data retrieval from spacecraft.
• Maintained and modified over 8 GDSCC Tracking Station Antennas used in the tracking of over 20 spacecraft.
• Responsible for testing, maintaining and modifying GDSCC Tracking Station equipment related to Digital and Antenna Servo systems and subsystems.
• Responsibilities include the implementation of Engineering Change Orders, troubleshooting and repairing failures using sub-system documentation, drawings and schematics.
• Researched and recommended network and data communications hardware and software.
• Monitored overall network performance.

• Responsible for conducting over fifty preventative maintenance checks quarterly on electronic and mechanical systems within RAM and CIWS systems.

• Reviewed and interpreted service manuals, specifications, wiring diagrams, and blueprints
• Used diagnostic and testing processes in collaboration with product engineers to identify, define, and solve development issues
• Diagnosed and repaired complex faults within target timeframes
• Performed acceptance testing and measurements on electronic components and assemblies to verify system compliance
• Monitored and tested equipment performance to diagnose and resolve problems
• Assembled, tested and maintained components and systems for high-performing electronics