Regulatory and Quality Assurance Leadership
Resume:
Julia C. Raye - Master Resume
Julia C. Raye
Alexandria, Virginia 22305
703-***-**** **************@*****.***
Summary of Qualifications
•B.S. degree in Chemistry with 30+ years of professional experience.
•Expert communicator, trainer, supervisor, team builder, and project manager.
•9 years of Regulatory experience including 2 FDA 510(k)s and a Shonin registration.
•Extensive experience with CE Marking, change control, risk analysis, MDR reporting, and
technical file updates.
•19 years of Quality Assurance experience in the manufacturing industry; 9 years in biopharmaceutical and food industry.
•Certified Power Investigator with 20+ years managing investigations, deviations, and
CAPAs.
•Direct FDA, EU, Canadian, and Japanese audit interface (over 6 FDA audits).
•Proficient in QA systems: TrackWise, LIMS, Agile, Documentum, Minitab, Oracle, and
SharePoint.
•9 years of management experience, supervising up to 29 staff members.
Knowledge of 49 CFR and 21 CFR Parts 210, 211, 300, 600, and 800
Professional Experience
Premier, Columbia, Md CAPA Investigator February 2020–May 2025
Trained on procedures used by personnel on the floor at the Bureau of Engraving and Printing (BEP).
Conducted investigations concerning the issues arising on the floor and supporting all manufacturing areas of BEP.
Ensured that products incoming and outgoing meet all standards set by BEP.
Reviewed batch records, gap assessments, PCAPA’s and non-conformances to ensure all work was compliant to the standards set by the Bureau.
Maintained spreadsheets of all CAPA’s and communicated with owners as to state to mitigate their CAPA until completion.
Raye Regulatory Auditors, Woodbridge, VA, and Augusta, GA Regulatory Auditor/Project Manager June 2014–Present
Audit chemical, pharmaceutical, plasma, biotech, and medical device companies for compliance purposes.
Conduct audits in FDA, EPA, EU, and JPAL regulations areas.
Work for government bodies such as EPA and state and Federal health programs, pharmaceutical and medical device companies.
Reviews batch records, gap assessments, Field Corrective Actions, CAPA, and non-conformances
Project management work for various companies-LPT, Inc., Baxter,
Manpower, Herndon, Va. Business Analyst/Project Management July 2019–August 2019
Audited Clean Room facilities for compliance to standard operating procedures (SOP). Project Management duties as assigned
Created Data analysis spreadsheets, and documentation.
Facilitated the creation of SOP’s.
System Pros, Inc., Billerica, Ma. Quality Auditor/Project Management December 2018–January 2019
Reviewed all procedures compliance documentation.
Performed Gap Assessment for current design systems documentation. Conducted audits for FDA, EU, and JPAL regulated areas documentation.
Reviewed current CAPA systems, and non-conformances for system robustness and compliance in documentation.
Completed Project management duties for medical device.
Service Source, Alexandria, VA Quality Assurance Auditor April–May 2017
Conducted internal audits to include QA and QC of all support personnel and their work. Analyzed trends, maintained data, and audited documentation.
Scheduled and coordinated external audit of vendors.
Evaluated the status of programs and recommended improvements. Aided in training and development of other internal auditors.
ImmunoTek, Hattiesburg, Burlington, Shreveport, LA Quality Assurance Manager June 2015–Jan. 2016
Maintained current knowledge of FDA, EU, and applicable state regulations in addition to customer specifications.
Audited all product shipments for compliance to Federal, state, customer, and ImmunoTek requirements
Ensured that proficiency test surveys and employee training were documented
Responded to QA Tracking and Trending errors, external and internal audit findings.
Recommended Corrective and Preventative Action Plans (CAPA) to Operations for implementation.
Monitored and evaluated adequacy of CAPA, completeness of reports, mentored staff in root cause analysis.
Oxford International-McNeil, Ben Venue, Hospira, Fort Worth, TX
Consultant (Contract) Jan.
2012–Nov. 2013
Reviewed and assessed audit observations and performed gap assessment of current Root Cause analysis plans in place.
Performed risk assessments as necessary.
Managed the closure of external and internal audits by documenting effectiveness checks and/or closure of actions completed along with carry over to a new CAPA.
Reviewed and assessed audit observations.
Set timelines for task completion and met with task owners to direct and guide required process documentation.
Tracked responses to CAPA’S until closure.
Reviewed Deviations in Track Wise system to close open events in a timely manner.
Performed gap assessments on each event as part of the review sterile manufacturing process.
Evaluated for completeness, identified for root cause, and appropriate corrective and preventive actions critical and major investigations of current plan in place.
Provided real-time mentoring and coaching as needed with respect to conducting and reporting investigations (i.e., process deviations, OOS, product complaint).
Reviewed protocols for equipment validation under CAPA action plans.
Tracked deviations in spreadsheet form to ensure timely closure of CAPA’S.
Collaborated with client face to face concerning CAPAs and critical action such as recall plans.
Solstas Lab Partner, Valdosta, GA
Quality Safety/Compliance Coordinator (Merger Closed) July–October 2011
Performed assigned internal audits and reports results to Corporate Compliance and/or Quality Director.
Was responsible for HIPPA compliance for CAPs and Medicare billing, testing, and result reporting.
Coordinated and participated in regulatory inspection activities and preparations. Maintained regulatory materials. Communicated regulatory readiness to laboratory directors.
Maintained knowledge of CLIA, OSHA, CAP, AABB, FDA, HIPAA, and Stark regulations.
Oversaw databases for employee competency, employee continuing education, and quality assurance monitors.
Developed, implemented, and maintained Compliance, Quality Assurance, and Safety programs for assigned Solstas locations, including policies/procedures to meet locations’ regulatory guidelines. Maintained data for programs.
Supervised activities of 29 Quality Assistants.
Acro-Johnson/Johnson Vision Care, Inc., Jacksonville, FL Regulatory Affairs Specialist/Project Management (Contract)
March–June 2010
Assisted project teams with identification of data requirements and coordinated the collection of data and documents to meet global registration.
Reviewed and updated the Technical Files in support of CE Marking of product for the European Union.
Updated and expanded list of contract venders for raw materials
Maintained technical files adding, changes to approved tests methods, approved sites for vendors, and substitutions in components.
Reviewed line approvals including labeling to update technical files quarterly and annually.
Reviewed changes in sales documentation and updates for clinical studies for assigned technical files for new products.
Added additional testing including, biocompatibility and toxicology data to technical files
.
Acro-Johnson and Johnson Vision Care, Inc, Jacksonville, Florida
Mar ‘10- June ‘10
Regulatory Affairs Specialist /Project Management – contract
Conducted and documented assessments of proposed change requests to determine regulatory impact.
Updated applicable standards to technical files
Completed project for review of process to access the Change control process and submission of FDA notification of Documentation to File process.
Reviewed packaging and labeling for new products as well as change control.
Prepared and submitted registration documents and periodic reports to FDA and other ministries of health.
Covidien, Plainfield, IN /Regulatory Engineer/Internal Audit Coordinator/Project Management (Plant Closed) Sept. 2007–Jan. 2009
Headed internal audit team. Confirmed internal quality matrix complied to QSIT sampling plan.
Trained subcontractors who were not required to have ISO or CE registration with their quality assurance program.
Functioned as lead auditor to maintain compliance in reporting of MDR and tracking service reporting. Trained quality assurance auditors for new regulations for new auditors ISO 13485, CMDR, and JPAL.
Updated labeling for medical device, due to changes in device design for technical files put into Agile.
Successfully completed two 510ks and a Shonin registration project.
Managed quality assurance audits from audit plan signature, audit report completion. Responsible for non-conformance reports from initial notification of designee to closure of final corrective action in a deviation management program. System designated non-conformances entered CAPA system.
Designated lead on CAPA’s for major non-conformances resulting from audits on quality system. Successfully completed 30-day response for root cause investigation and effectiveness checks.
Prepared monthly highlights, biannual management review reports with audit metrics and provided statistical feedback (using Minitab and other programs) to management.
Covidien, con’td
Completed documentation to NSAI, TUV Rhineland and TUV Industries Services for three significant changes and two non-significant changes. Contacted notified bodies directly concerning welder’s certifications, annual audits, and witness builds.
Oversaw project with notified bodies for review of technical files and to establish changes in Declaration of Conformity B and C in America.
Taped to head Project for Declaration of Conformity for new accessories in Latin America and make electronic forms.
Supplied documentation to NSAI, TUV Rhineland, and TUV Industries Services for three significant changes and two non-significant changes. Contacted notified bodies directly concerning welder certifications, annual audits, and witness builds.
Maintained direction of CE markings through notified body audits and trained facility under ISO 13485. Worked with supplier auditor to ensure vendors maintain CE certifications. Created training program to assist vendors in maintaining a minimal level of quality where no CE marking is required.
Battelle Memorial Institute, Center for Disease Control and Prevention and Aberdeen Proving Grounds, Columbus, OH LRN-C Quality Assurance Chemical Terrorism Program Assistant Director Project Management (Contract)
August 2003–June 2006
Audited laboratory, instruments, procedures, and data packets for compliance to U.S. Army, Federal, State of Maryland, local APG, and internal requirement.
Performed surveillance audits as personnel performed tank monitoring for chemical demilitarization project
Provided QA oversight during agent monitoring, non-agent monitoring, hazardous waste sample collection, chemical agent extraction analysis of process control and hazardous waste samples
Trained the state public health laboratories on quality assurance requirements for participation in the Laboratory Response Network-Chemical Terrorism Program.
Created quality assurance plan from CLIA, EPA and FDA requirements.
Designed and maintained document system that recorded the capability of state and territorial laboratories to respond analytically to acts of chemical terrorism.
Created a notification system for vendors of Proficiency Tests and eligible laboratories to ensure that all eligible participants received samples as needed.
Battelle cont'd
Created process that was used to notify laboratories on status of validation and proficiency test results.
Performed statistical calculations to determine validation acceptance.
Responsible for all shipments to state laboratories from quality assurance program. Implemented new materials program for validation and proficiency testing of laboratories
Fielded all questions for LRN-C QA program.
Alpha Therapeutic Corporation, Jacksonville, Florida QA Specialist – Co. Bought out
June ‘01-Aug ‘03
Evaluated regulatory and technical compliance to cGMPS from FDA by overseeing all manufacturing processes within the donor center.
Responsible for HIPPA test reporting and tracking of positive results.
Tracked and trended deviations and reviewed corrective and preventative actions (CAPA).
Reported gross deviations to FDA through investigations and Biological Product Deviation Reports.
Evaluated donor center compliance utilizing government regulations for the evaluation of donor center compliance, operating procedures and industry standards.
Conducted regular center audits and reported monthly on equipment maintenance, calibration records, and donor records
Released product shipments
Verified the disposition of unsuitable units
Acted as liaison between all external auditors and center management and corporate entities.
Performed annual cGMP training for center.
Department of Health, Jacksonville, Florida Chemist II Oct ‘00-June ‘01
Reviewed quality assurance plans from laboratories applying for or renewing certification through the National Environmental Laboratory Accreditation Program (Criteria for all quality assurance programs were based on cGLPs from EPA Guide 25(ISO 17025)
Fielded questions concerning application procedures, development of Quality Assurance Plans and eligibility based on successful completion of proficiency tests.
Documented and assessed all proficiency tests performed by laboratories participating in the NELAC program.
J. A. Jones, Kings Bay, Georgia Laboratory Supervisor- contract
Aug ‘99-Aug ‘00
Monitored water, wastewater, and industrial waste facilities. Developed a new Quality Assurance program
Prepared laboratories for NELAP accreditation
Updated standard operating procedures utilizing testing requirements from the EPA and Georgia Department of Natural Resources.
Reviewed and submitted all permit data to EPA and State agencies.
Oversaw compliance monitoring for the state of Georgia and; analyses and reporting of hazardous wastes generated by the base.
Supervised the facilities that processes all water and wastewater utilized or produced by the base as well as any waters released to surrounding bay
Responsible for laboratory compliance for company acquired ISO registration
Enviroplan Consulting/Department of Natural Resources, Augusta, GeorgiaSept. ‘98-August ‘99
Field Technician- contract
Monitored air quality samples for the city of Augusta. Audited and maintained sample equipment.
Processed and recorded data from sample analyses.
Packaged and shipped samples to Georgia Department of Natural Resources
Maintained log of sample dates, conditions and data.
Performed calibrations and audits as required by government sanctioned standard operating procedures
Participated in audits from the state of Georgia and Environmental Protection Agency.
Performed the same task for the cities of Athens, Savannah, Albany, Douglas, Brunswick, and Macon.
Rutgers Organics, Augusta, Georgia Laboratory Technician/Laboratory Manager. Aug ‘96 to July ‘98
Analyzed herbicide and pesticide intermediates by gas and high-pressure liquid chromatography.
Maintained database of analyses results.
Designed a storage system for solvents and supplies used in the laboratory.
Tested raw materials for chemical component and moisture content.
Reported off specification results of waste water to city authority.
Served as a member of the safety committee and training
Served as an internal auditor for ISO 9000 certification.
Completed tasks of supervisor during interim for new supervisor
UCB Chemicals Incorporated, North Augusta, S C Laboratory Analyst Jan ‘94 to Aug ‘96
Used standard operating procedures to analyze in process and final product resins and powders to assure purity and chemical composition.
Responsible for final product testing for consistency, durability and stability.
Detected unknown concentrations of metals and toluene in waste water by AA and GC with purge and trap attachments.
Used computer system to report and store information for all analyses reported from the laboratory.
Responsible for organizing laboratory and laboratory retain storage. Received certification as Hazardous Waste Operator.
Established work processes during laboratory certification-ISO 9000
Castleberry’s, Augusta, Georgia Quality Control Technician-contract Sep
’93 to Dec ‘93
Performed quality checks on production floor (weight, sanitation, raw materials) Maintained records according to USDA/FDA standards and cGMPS.
Checked temperatures of retorts, incoming produce and pots (Sterilization).
NAudited cooking areas for condensation buildup and contamination.
Performed regular magnet checks for purity of product.
Chemtronics –Kennesaw, Georgia Chemist June
‘92 to June ‘93
Gwalia USA. LTD. McCormick, South Carolina Chemist
September ‘90 to Jan ‘92
Analytical Biochemical Laboratory Columbia, Missouri Chemist
June ‘89 to Aug ‘90
Education
Bachelor of Science, Chemistry – Paine College, 1988
Training, Certifications, and Research
•Gwalia USA – 24 hours of New Miner training (MSHA, 30 CFR Part 46)
•Hazardous Waste Operator – 40-hour training
•Rutgers Organics – ISO 9000 Internal Auditor
•Alpha Therapeutic Corporation – Reception, Donor Floor, and Plasma Areas Certification
•Saf-T-Pak – Transportation of Dangerous Goods
•CDC – Safety Survival Skills Parts I & II; Blood-borne Pathogens; Environmental Awareness I & II
•Power Investigator – Training and Certification
•TrackWise Investigator – Training and Certification
•ISO 13485 – Training and Certification
•SMART ISO 9001:2015 QMS
•Change Control Board (CCB) Training
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