• Drafted Validation protocols, SOPs, and other documents related to validation activities.• Performed QA document review of Validation IQ/OQ/PQ protocols and reports.• Reviewed Turn Over Packages (Qualification Package) for new equipment and equipment requiring revalidation due to scope of project (Company acquisition/new process).• Drafted User Requirement Specifications (URS) for equipment on the site to align with corporate procedures and requirements.• Initiated change controls for the Validation and Engineering group and drove CAPA action items related to validation group.• Provided Quality oversight for deviations and compliance questions related to project scope. • Interacted directly with client Quality Assurance and Validation Managers to ensure successful deliverables in a timely manner.• Tracked training requirements/compliance of consultants on the project to ensure training is up to date for project execution.• Used Document Management System (Smartsolve) and Regulatory Asset Management System (RAM) for project related activities.

• Assisted with Laboratory Systems audit.• Reviewed Standard Operating Procedures to ensure GMP compliance and made recommendations to enter state of compliance.• Performed gap analysis of Laboratory Quality Systems including validation and calibration program.

• Assisted with the Site Remediation Plan to address CAPAs/Deviations within the scope of the FDA observations. • Team Lead for approximately 10 consultants; managed work-stream to meet FDA commitments/deadlines.• Successfully met FDA deadline three months ahead of schedule. • Provided weekly metrics to management related to progress of the team.• Assisted client with creating a training program/slide presentation for cGMP and Quality Systems Training; participated in the training sessions.• Provided gap assessment feedback to management to improve overall Quality Systems.

• Addressed backlog of Root Cause Investigations, Confirmed Complaints Investigations and CAPAs through Quality remediation plan while working on current priority investigations that may affect product release. • Responsible for ensuring compliance with relevant Standard Operating Procedures while gathering, analyzing, and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint had on the product, process, patient health and safety. • Gathered information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations; Authored Test Plans and Study Protocols/Summary Reports as needed to support Investigations/CAPAs/Change Controls.• Prepared and analyzed manufacturing and laboratory analytical historical data, and used methodical root-cause analysis tools to determine root causes and effectively communicate the root cause to senior management. • Properly assessed the manufacturing and/or analytical environment, independently conceived and advised senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process by using industry accepted analytical tools.• Provided technical expertise to ensure that investigation corrective and preventative actions were complete, thorough, accurate, and timely. • Worked independently to comply with procedure driven guidelines relating to deviation and complaint investigations and made decisions that directly affected patient health and safety. • Ensured that deadlines were maintained and closely monitored the need for extensions in relation to CAPAs and Investigations.

Independent Pharmaceutical, Biotech & Medical Device Consultant specializing in remediation efforts following FDA observations and proactive compliance gap analyses of Quality Systems. Currently working assignment with major pharma company (OTC products) Batch Record Review- helped get a major brand name back on market; Reduced back log of APRs/Team Lead for Annual Product Reviews.

• Analyzed chemical components for compliance and quality gaps for large pharmaceutical company- CPAT Project (Comprehensive Product Assessment & Trending) • Reviewed non-conformance investigations/CAPA’s for OOS and trending data for many critical products.• LIMS template/Compendia (US/EP/JP) review to ensure tests are in compliance with NDA filings to FDA. • Made observations and recommendations regarding compliance gaps. • Assessed each chemical component of the critical products for compliance with Residual Solvent/Melamine testing per ICH and FDA guidelines. • Reviewed procedures to ensure validations were in compliance with the Regulatory NDA filing to the FDA, and current per ICH and FDA guidelines.nalysis and compliance assessment of all their products.

• Assisted with the backlog of batch records (total of 800-many on the FDA’s drug shortage list) by performing Quality Technical Data Review.• Through diligence and long hours, more than half of the drugs are already on the market in less than three months. • Consulted with management and other consultants that were brought in to help improve overall quality of lab and company by listing changes to be made in procedures and lab performance.• Ensured quality and compliance was exercised daily while reviewing test procedures, lab notebooks, batch records, test results, investigations, etc. • Used my knowledge in the industry and with FDA audits to suggest improvements that need to be made to be in compliance following warning letters and observations the company had recently received.• Empower II, Chemstation, AS400, Nugenesis, LIMS, LabX, Trackwise, Microsoft Office, and Excel used daily.

• Played vital role in setting up Quality Assurance department during the transition from clinical company to commercial facility. • Met challenges and deadlines in preparation for many FDA audits prior to receiving commercial license. • Assisted with cGMP internal and external audits. • Trained new hires and assisted with training programs. • Performed batch record reviews, closure, and disposition using Oracle software. • Coordinated data and documentation review and analysis. • Processed and often initiated deviations and non-conformances. • Wrote documents, standard operating procedures and technical reports. • Represented Quality department in cross-functional teams, projects and GXP-related problem resolution. • Used professional concepts and company policies and procedures (SOP’s) to solve a variety of problems. • Member of the Environmental Health & Safety Committee. • Project manager for the “Toys for Tots” Program. .

• Performed finished product, stability, and raw material testing on a variety of controlled and non-controlled pharmaceutical products.• Generated and reported data in a timely manner; Conducted peer review of laboratory documentation.• Performed wet chemical and instrumental analysis including HPLC, UV Spectrophotometer, Gas Chromatography, Dissolution, Disintegration, Centrifuge, Karl Fischer, FTIR, Specific Gravity, etc.; Use Waters Empower I and II Software for HPLC and Chemstation software for GC. • Performed daily checks and calibration of analytical instrumentation and determined system suitability. • Maintained GLP/cGMP environment within the laboratory.

• Perform incoming, in-process, finished product, and stability testing to determine whether tested materials meet established acceptance criteria.• Perform wet chemical and instrumental analysis including HPLC, UV Spectrophotometer, and Gas Chromatography.• Analyze raw materials using USP/NF/FCC or in-house developed testing methods.• Analyze deionized water system and determine its acceptability to determine whether water produced by the system meets established acceptance criteria.• Prepare, qualify and maintain sample test solutions, standards, and reagents.• Assist the Validation Scientist and others in regards to process validation testing, instrument qualifications, method validations, method development and special request for laboratory analysis.• Maintain GLP/GMP environment within the laboratory.• Write and update Standard Operating Procedures and Laboratory Methods• Perform daily checks and calibration of analytical instrumentation and determine system suitability• Maintain accurate laboratory notebooks and conduct peer review of other analyst's data to ensure accuracy and completeness.• Report results to appropriate supervisory personnel.

• Honors Graduate from HR Program, FT. Jackson, SC- 2005• Received the Army’s Physical Fitness Award -2005• Received (2) Achievement Awards- 2005• Assisted in the field Medical Facility as a phlebotomist and medical assistant while in Rambala, Panama, 2007.• Assisted the medics in my unit by drawing blood on over 100 soldiers during routine military exams for other units, and for soldiers getting ready for deployment overseas, 2008.

• Performed blood draws on patients, including the elderly, infants, and “hard sticks”.• Attended to stat draws with a sense of urgency.• Logged in blood samples and distributed to proper areas in the lab for testing.• Utilized a tube system to send samples directly to the lab from different areas in the hospital.

• Assisted with the Global War on Terrorism History Project.• Conducted interviews with commanders who have led missions in Iraq and Afghanistan.• Transcribed interviews to present to the National Guard Bureau for the State of NH National Guard missions.

• Instructed students in the areas of General and Advanced Chemistry.• Planned lessons daily for lecture and lab.• Demonstrated effective presentation skills.• Worked 1:1 and in groups with students that have learning disabilities.

• Assisted in the examination and treatment of patients.• Measured vital signs such as pulse rate, temperature, blood pressure, weight and height.• Gave injections, treatments, and performed routine lab tests.

• Interacted with the public on a daily basis in emergency and non-emergency situations.• Acquired the ability to handle high-stress incidents and make immediate decisions when necessary.• Learned how to work as a team member with other operators, .dispatchers, and officers.• Strengthened communication skills.

• Assisted the Nuclear Medical Technologists with the administration of nuclear medicine to cardiac patients.• Learned how to start IV’s and perform EKG’s on patients.• Actively involved in administering stress tests.• Assisted in the post-stress test imaging process.