Victoria J. Shelton
3910 Red Leaf Court Pt. of Rocks, MD 21777 firstname.lastname@example.org (301) 803-9524
I am a result driven professional, with over 20 years combined experience in the Biotech. Pharmaceutical and Device Industries. I am seeking a challenging position to utilize my skills and knowledge to the fullest.
SUMMARY OF QUALIFICATIONS
Over 20 years experience: 6+ years experience in the Biotech Industry, 14+ years experience in the pharmaceutical Industry and approximately 2 years in the device industry.
FDA, EU, GXP, ICH, CBER, ISOs, GAMP 4/5, GEPs, Biologics (21 CFR 600, 601, 610), 21 CFR Part 11 compliance, System Development Life Cycle (SDLC) methodologies, Engineering best practices, device (21 CFR 820), Six Sigma, and Total Quality Management.
Interacted with the FDA on three separate audits concerning the calibration quality system. No 483’s or negative observances made.
Electronic and Technical Expert with processes, equipment, software and automation.
Software, Part 11 Assessments, Code Review, Change Control Management, Commissioning, Validation (VMPs, FRSs, SDDSs, URSs, IOPQs), Infrastructure, Risk Analysis, GAP Analysis, Quality Assessments (various equipment operating software, Emerson Delta V, Siemens Apothogee BMS system, Allen Bradley PLC to name a few.
Biotech processes/equipment/operational software (CIP/SIP, bioreactors, tanks, WFI, USP, RO Water Systems, Pall Purification Skids, autoclave, software/automation), Solid dosage processes/equipment, (fluid bed dryers, tablet compression, granulation, automation/software) topicals, aerosols, sterile processes/equipment and Laboratory equipment (VITEK32, Perkin Elmer Atomic Absorption, environmental chambers to name a few).
Biomedical IT Quality/Regulatory Management Infrastructure Aug 2010 to Current
American Red Cross Ashburn, VA
Providing Quality/Regulatory oversite/support IT infrastructure/software teams during nsure adherence to policy and procedures,
FDA regulations and Consent Decree pertaining to Biomedical IT .
Interact on cross functional teams to support the maintenance of the infrastructure in a manner consistent with applicable FDA and blood industry regulations.
Providing Quality and Regulatory oversight and guidance for the design, development, testing and implementation of information technology (IT) infrastructure systems supporting biomedical software applications, promoting an effective risk-based approach. Supporting improvements in our compliance profile. Ensuring adherence to ARC System Lifecycle Activities.
Critical Problem Management Reports for regulated network, application or device outages. Ensuring proper root cause and resolution are achieved and reported. Ensure vendors are following regulated guidelines and using best business practices. After hours on-call to perform a Quality/Regulatory over sight and approval for Regulated application/network outages resolution, root cause analysis, reoccurance.
Serving on the several BioArch R2 teams (Data Migration, End to End Testing, Full Site Validation, Infrastructure) for Quality and Regulatory over sight on the infrastructure side and as needed support for the software side for ePROGESA (a web-based system) that will be used as the blood system of record; this allows the Red Cross to be able to deliver ISBT 1281 labeled products to customers. Ensuring traceability to requirement.
Serve as a voting board member for IT Critical Change Request. Supporting Life Cycle Activities for regulated applications and devices. Ensuring FDA.procedrual adherence. Support Best practices.
Quality/Regulatory team member on the projects such as Infrastructure Technology Refresh Program intended to modernize, enhance, and extend the American Red Cross information technology (IT) foundation by Virtualizing environments and upgrading our technology (cloud computing). My role is to ensure implementation of the infrastructure quality program according to project, process and contract requirements and objectives. Ensures that project and process control documentation are compliant with requirements, objectives and/or contract, Risk Assessments are adequate and all risks properly mitigated. Continual process improvements are implemented.
President/Director of Consulting Services March 2007 to Aug 2010
Pharmaceutical Compliance Concepts Inc. Morrisville, NC
(Currently sub-Contracted Magellan Bioscience and previously by MedImmune, for the Gaithersburg and Frederick MD sites)
For Magellan Bioscience at their Chantilly, VA Dynex facility, my duties are to provide quality over site and project management for the global conversation from an Oracle Enterprise Resource Planning System (ERP) to a Windows ERP System project. Cost Savings to the company.
Audited for gaps in compliance and quality testing. Completed development of OQPQ, by adding site specific testing such as Material Resource Planning testing. Recommended and developed IOQ which includes infrastructure and software installation verifications.
Directed the Validation efforts. Working with the different departments to expedite testing to ensure validation is completed prior to the Oracle ERP license expiration. Ensure proper documentation and (Screen captures) for testing.
Authored Magellan Global Procedures for Life Cycle Development and Change Control Procedures.
With MedImmune in Frederick, MD from served as Technical Expert for the development/execution of Engineering Development Studies for Lab and USP Water systems, bioreactors and other product related equipment. Process Optimization.
Commissioning and Qualification life cycle documentation development, execution for process utilities (WFI, RO, USP) and equipment (bioreactors). Mentor junior levels on appropriate real time testing techniques and validation strategy.
At MedImmune, Gaithersburg, my duties as a Technical Services Engineer for the Clinical Validation Department included technical support/training, and Validation strategy development. Developed/executed Part 11 compliance for process equipment/systems. Life Cycle Documentation Development. Performed I/O checks and simulation of alarm/interlock testing for the Allen Bradley PCS system. Siemens BMS system, Pall skids, autoclave, bioreactors, tanks and CIP/SIP processes insured Part 11 compliance and Life Cycle documentation.
Then progressing into Project Manager for Technical Services-Development at MedImmune Gaithersburg, MD performed process and equipment deviation investigations. Provide detailed report with cause and effect along with resolution.
Developed RSMACC software FRS. Authored the site procedure for the SOP for the Administration/Use of the RSMACC Software for Traville Site.
Provided Management and Quality oversight of 12 contractors for Preventive Maintenance shutdown activities for the process equipment, developed compliance accountability documentation. Completed one week ahead of schedule and 25% under budget.
Performed a quality assessment of batch records and SOPs, edit as necessary for quality, clarity or safety. Trained calibration/validation engineers on equipment, automation, proper technique.
Software Instrumentation and Validation Engineer III Nov. 2006 to Feb. 2007
Digene Corporation (Device Manufacturer) Rockville, MD
Instrumentation Engineering Department
Ensured regulatory requirements for medical device were met and applied consistently for commercial product DML 2000 Luminometer and for any vendor firmware revisions; insure Part 11 compliance through testing.
Developed Software Product Requirement Specifications, Master Validation Plan, Microsoft Project timeline, Risk Analysis, and Validation Protocol documents (IOQs) for Phase I/II.
Developed departmental procedures for the Control and Administration of passwords for software used by the department to meet FDA regulations.
Maintained the Luminometer Software System Life Cycle documentation.
President/Director of Consulting Services June 2005 to Nov.2006
Pharmaceutical Compliance Concepts, Inc. Morrisville, NC
(Contracted by Human Genome Sciences, Rockville, MD – Process Controls Dept first through Oxford Global Resources then my own company PCC was awarded to contract.)
HGS – Provided Project Management and Quality oversight for Facility Software Automation/Process Controls MEC Delta V project and the Facilities Monitoring Control System (FMCS) Siemens project. Developed/ Executed Process Software Control Validation Protocols (VMP, CPs, IOQs, includes Part 11). Helped develop departmental System Life Cycle procedures and policies.
Developed, managed the Software Engineering Change control process for the Delta V then chaired the weekly Engineering Change Committee meetings.
Provided Quality oversight for the Process Controls MEC Delta V project and the Facilities Monitoring Control System (FMCS), Siemens project for the New Large Manufacturing Facility.
Generated Software Validation Plans, Functional Requirements Specification (FRS), System Detailed Design Specification (SDDS), User Requirements, and IOQs for the -Siemens Delta V control system.
Sr. Validation Engineer Oct. 2004 to Feb. 2005
Validation Technology Inc. (VTI) San Diego, CA
(Contracted by Amgen, Rhode Island then Applied Molecular Evolution, San Diego, CA)
Applied Molecular Evolution, San Diego, CA – Developed Design Requirements, test plans, traceability matrixes, and performance qualification for the Facility Air Handling systems.
Amgen, Rhode Island – Developed Design Requirements, test plans, traceability matrixes and perform IQ/OQ/PQ for the Facility (Air Handlers, refrigerators, freezers, pH meters, balances, Atomic Absorption, Computer control systems (Delta V) and 250 liter Tanks CIP/SIP and various laboratory equipment to name a few this also included Part 11 execution for the systems w/software.
Performed GAP analysis, developed and edited Standard Operating Procedures as necessary.
Sr. Validation Engineer Jan. 2003 to Sept. 2004
Stryker Biotech (Device/Bio Manufacturer) Hopkinton, MA
Managed the day to day activities of the validation department (5 people) in absence of Manager. Team motivator. Assist with professional development.
Initiated, reviewed and/or approved failure analysis/resolution reports (CAPA), validation protocols, change requests, deviation closeout for validation. Ensure regulatory requirements were met for the device/bio product process.
Provided Project Management and Oversight for the cross-functional teams for the Warehouse expansion project to ensure completion will all activities in a timely manner i.e.construction, engineering, warehouse personal, QA, calibration and validation.
President/Director of Consulting Services Dec. 2002 to Dec. 2003
Pharmaceutical Compliance Concepts Morrisville, NC
(Contracted by DSM Pharmaceuticals, Greenville, NC 2 employees placed at Bayer in Clayton, NC)
Managed and developed all aspects of the Business, itemized customer work proposals, Invoices, project timelines and updates. Supported employees both professionally and personally to achieve their full potential. (3 Permanent employees)
Developed and conducted quality audits for internal departments and vendor audits for regulatory compliance.
DSM – Developed and executed (IQ/OQ/PQ) validation protocols, traceability matrixes, GAP Analysis, and Part 11 Assessments for computer control systems (laboratory equipment, FTIRs, VITEK 32).
Validation Engineer May 2001 to Dec. 2002
Day and Zimmermann International Raleigh, NC
(Contracted by Wyeth, Sanford, NC Sterile Facility then by Bayer, Clayton, NC Sterile Facility SFF)
Wyeth – Audited the Calibration department for adherence to policies/procedures for the Regulatory Department. Reported discrepancies and recommended solutions.
Performed Part 11 Assessments, GAP analyses, defined User Requirements; IQ/OQ/PQ protocol development/execution (software/operational) for all QC and Chemistry laboratory equipment.
Bayer – Executed (IQPQ) software validation for the RMARS (Recipe Management and Alarm Reporting System) and SCADA (Supervisory Control and Data Acquisition) systems that serve the sterile area equipment.
Developed and executed validation protocols (IQ/OQ/PQ) examples, Freezers, Oscillator, Software Validation for Differential Pressure Monitoring System and Sterile Mfg. Systems/Processes.
Metrology Supervisor Feb. 1997 to May 2001
Eisai, Inc (Pharmaceutical, solid dosage, sterile) Research Triangle Park, NC
Selected, hired and developed a metrology/instrumentation team using in-house and contract personnel (8 employees) for troubleshooting, repair and calibration for equipment for solid dosage, packaging, sterile pilot plant, QC/QA labs, utilities and the warehouses.
Developed departmental procedures, negotiates yearly departmental budgets, selected Calibration Software tracking system, and developed all validation protocols for the execution for compliance of software system.
Managed, investigated, tracked to ensured resolution with timely closeout for OOS, OOT, deviations and CAPAs pertaining to equipment, software and processes.
Assisted with technological transfer, trained personnel in calibration/validation best practices.
Interacted on two separate occasions with the FDA, defended Quality System for Calibration/Preventive Maintenance No observations or 483s.
Metrologist June 1996 to Feb. 1997
Fluor Daniels Research Triangle Park, NC
(Contracted by Biogen, RTP, NC (biotech)
Provided Engineering support with the start up of a new sterile facility, which included installation, programming process controls, troubleshooting, repair, calibration, and commissioning of equipment and systems and related engineering/support documentation.
Setup, calibrated and operated validation equipment; managed Life Cycle documentation, calibration system and standards for FDA compliance.
Instrumentation and Controls Engineer Sept. 1986 to June 1996
Glaxo, Inc (Pharmaceutical solid dosage, aerosols, topicals) Zebulon, NC
Started as an Electronics Engineer then was promoted to I&C Engineer. Developed departmental standard operating procedures. Solid dosage/topical/aerosols/cephalosporin instrumentation support. Performed training of junior technicians.
Met with the FDA on the Calibration Program Quality System. No observations or 483s.
Assisted with scale-up of product from the Pilot Plant to large scale.
As an electronics technician, monitored/repaired/programmed critical facilities support systems and the Johnson Controls BMS system. Provided 24-hour corrective action in the event of any failures throughout the facility.
Performed installation, commissioning, troubleshooting/repair, and calibration of electrical, mechanical, and pneumatic controls for utility systems in the facility.
Received numerous process improvement awards.
Bachelor of Applied Science, Management, Campbell University, 2003
Associates of Applied Science, Electronics, Cape Fear Technical College, 1986
Sustaining member of the International Society of Pharmaceutical Engineers (ISPE) all concentrations
5 Yr. Member of the Parenteral Drug Association (PDA)
4 Yr. Member of the Instrument Society of America (ISA)
All Core competencies completed for the Associates Degree program for Automation/Robotics 6 robotic languages used hydraulics and pneumatics training.
Ongoing monitoring of the FDA and other industry sites to keep abreast of any possible emerging industry standards.
Continuous cGMP and Environment Health and Safety Training (internal and external client sites)
Effective Project Management w/Microsoft Project 2003; Rockhurst University
Supervisor Workshop; Dunn & Bradstreet, Raleigh, NC
Blue Mountain Calibration Software (CalMan) & Crystal Reports, Atlanta, Georgia
Kaye Validator (KL) and Thermocouple Training, Raleigh, NC
Allen-Bradley PLC-5 Training, Charlotte, NC
FLUKE – Principles of Metrology, Altamonte Springs, Florida
AutoCAD Training, Raleigh, NC
ISPE Training on the following:
Risk Based Approach to Compliant GxP Computerized Systems (GAMP 5)
Good Automated Manufacturing Practices Guide for Validation of Automated Systems (GAMP 4)
PAT Process Analytical Technology
Validation of Process Control Systems
Guidelines to Commissioning and Qualification