Documentation Specialist and Reviewer

Janine R. Purdy

Elmira, NY ***** / 607-***-****

adzmh4@r.postjobfree.com/www.linkedin.com/in/janine-purdy Professional Summary

Extensive experience as a Quality Professional in various roles, using inspection, investigation and data analysis techniques towards process and quality improvements in order to achieve compliance goals. Specializing in documentation and data review for highly regulated industries for accuracy and error prevention, reliable and trusted with significant assets and sensitive information.

• Knowlegeable of OSHA standards for health and safety, Quality GMP/GDP compliance requirements

• Experience in conflict resolution with customers, vendors, suppliers and personnel Qualifications

• Significant cross functional experience in Quality roles, Fire Service and Emergency Medical Services

• Quality Management Systems, medical device industy, external and implantable, documentation control, internal/external audits, Post Market Surveillance/customer complaints, and Safety teams

• ISO 9001, ISO 13485, 21 CFR Part 820, ANVISA, NIMS, FEMA, NFA, ICS, GMP, cGMP, MDR, GDP

• Interacted daily with Manufacturing processes including- raw materials,machining, chemical finishing, inspections, sterilization. Packaging, labeling, review, NCMR, and archival of final documentation.

• Ongoing and extensive training within Fire Service and EMS in leadership roles strengthen and compliment personnel interactions, critical thinking and commitment to improvements

• Utilize full MS Office Suite- Word, Excel, Outlook, Teams, and different operating Systems (SAP), etc.. Relevant Experience

Golden Glow Volunteer Fire Company Pine City, NY

Assistant Chief, NY State Registered EMT- 2004-Current

• Respond to and provide rescue/medical care for emergencies, vehicle crashes, structure fires, as well as River Rescue Task Force, Airport Task Force and mutual aid with various Fire Apparatus and equipment.

• Communicate with dispatch, other firefighters and law enforcement as incident command to relay vital infermation concerning need for additional resources or situational changes

• Oversees activities of firefighters on calls, provides training and guidance/support to members, actively participating in drills, and attending further education classes and trainings to stay current on changes Rheonix Inc. Ithaca, NY

Quality Control Analyst- June 2022- December 2022

• Performed extensive review of DHR documentation for errors, tracked and summarized results for continuous improvement project and management review, resulting in implementing fomatting/spacing changes to reduce illegible entries and rewriting the SOP for documentation compliance

• Participated in observational training of internal audits of process for manufacturing and receiving areas Transonic Systems, Inc. Ithaca, NY

Quality Associate- August 2019- December 2021

• Managed the facilitation and maintenance of all calibrated devices for accuracy, location, service issues for entire company, including Japan, Taiwan and Europe for over 1000 devices.

• Processed daily Post Market Surveillance for customer complaints involving reportability criteria, risk management, from initial determination escalating to CAPA

• Managed the SDS records and labeling system and spearheaded the the upgrade of records from SDS to GHS compliance/safety and was an Emergency First Responder for entire plant

• Weekly collaboration with MRB team for disposition of non-conforming products, maintained access and organization of secured MRB cage for NC products, broken equipment and special materials

• Regular completion of NCMR's, Purchase Orders, Requisition forms, Vendor Audits, calibration requests, equipment inventory tracking and labeling

• Provided support to all levels of audits, in-cell, internal process and external- both backroom and direct Johnson & Johnson Horseheads, NY

Senior Inspector in Final Acceptance/DHR- May 2014- August 2019

• Responsible to inspect, review, verify, obtain correction for (or quarantine any NC) all implantable medical product we made including paperwork that accompanied each set of parts- from raw materials, maching, chemical finishing, inspections, sterilization, packaging, labeling and laser etch for any non- compliance issues prior to final release every day without error consistantly and reliably

• Maintained a stellar zero error record and audit compliance readiness at all times at DHR

• Weekly in-cell qualification audits of process for compliance, and participated regularly in ongoing, planned and unplanned internal and external regulatory body audits, including TUV and FDA

• Volunteered to learn the new SAP operating system and become a change agent (trainer) to other employees ahead of a company ownership transition

• Performed regular bench inspections to support the quality team during heavy demand times

• Designed and developed a gage holder with the Engineering team for the inspection team to address ergonomic issues and selected as Safety Coordinator for the 2nd shift with over 250 people Education

Corning Community College-Associate of Science Corning, NY

• Dean's List, President's List, Honor's Forum Member – GPA-4.0 Over 49 certifications from several agencies including FEMA, Paradigm, State of New York Emergency Management Office, Guthrie, New Mexico Tech, Mercy Flight, NY State Department of State OFPC, Depuy Synthes and Johnson & Johnson.

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