Christine Scheaffer Email & Phone Number

Bethlehem, Pa

Monitored and maintained the Quality Management System for facility compliance with FDA 21 CFR 1271 which resulted in errorless inspections.• Ensured facility registrations, regulatory binders and investigations were documented and maintained appropriately to help ensure a constant state of inspection readiness.• Authored, prepared and submitted: FDA MedWatch 3500A and (BPDR) Form FDA 3486.• Documented, maintained and responded to oral and written communications with regulatory, governing and state bodies.• Assisted in the development and maintenance of new policies and procedures, regulatory files, records, and reporting systems.• Served as a Regulatory representative at the East coast facility and provided regulatory guidance for staff.• Communicated with surgeons, requesting additional information based on post-operative reporting.• Compiled tables on QA Events to keep track of CAPA and Root Cause analysis.• Reviewed and edited Quality Management System policies and procedures, for clarity, accuracy and compliance with US FDA 21 CFR 1271 Regulations as well as New York state and EBAA Medical Standards.• Reviewed customer complaints for safety issues; non-conformances and CAPAs for effectiveness.• Monitored and coordinated local internal policy and procedure development and implementation.• Drafted and executed validation protocols for refrigerator environmental monitoring systems; Sensaphone and PharmaWatch.

Exton Pa

Performed analysis per procedures (EPA, SW846, SM); pH, % solids, moisture and Ash, TSS, TDS, BOD, Total and Reactive Cyanide and Sulfide, Turbidity, Hexavalent Chromium, Phosphates, Alkalinity, Hardness and Conductivity which aided in environmental hazardous waste clean up. • Set up, operated, calibrated, troubleshooted and maintained laboratory equipment; muffled furnace, Buret, pH meter, extraction, digester, scrubber, and distillation, Thermo Genesys UV visible spec., VWR drying oven, Nitrogen Evaporator, and centrifuge.• Performed data entry using Excel and LIMS; Element, Promium.• Prepared samples for GC and LC analysis; liquid to liquid extractions.• Maintained laboratory supplies, cleanliness and organization.

Reading Pa

Performed a variety of QA laboratory testing which resulted in product distribution ahead of schedule.• Received and decontaminated returned medical devices. • Performed physical analysis, simulations and testing in an attempt to verify the complaint.• Documented complaint investigations data using Trackwise database.• Performed environmental monitoring; viable, non-viable, surface bioburden, and sterility.• Performed Endotoxin (LAL) testing Kinetic-Turbidity, Gel Clot, and Chromogenic Methods.• Performed sample management using LIMS computer program.• Assisted in new product Validations and performed equipment IQ/OQ/PQ testing.

Exton, Pa

Successfully led five QC Lab technicians in the completion of wet chemistry and microbial testing which resulted in product distribution ahead of schedule. • Performed material analysis per procedures; pH, % solids, fat, ash, nitrogen Pb, Cd, As, Hg, moisture and tensile.• Set up, operated, calibrated, troubleshooted and maintained laboratory equipment (Büchi fat extraction, digester, scrubber, and distillation, UV visible, Thermo Elemental AA, CEM microwave furnace, Orion pH meter, depyrogenation ovens, moisture meter, and Instron).• Performed environmental monitoring; viable, non-viable particulate, surface bioburden and sterility.• Performed Endotoxin (LAL) testing, using Kinetic Turbidity and Gel Clot Methods.• Performed microbiological testing per USP, bioburden by pour plating, water testing, filtration and growth promotion using aseptic technique.• Inspection, QC and lot dispositions of raw materials, in process and finished products.• Analyzed, trended and maintained data. • Revised and maintained SOP’s.• Performed IQ/OQ/PQ testing of new equipment and performed new product Validations.• Maintained MSDS system, laboratory supplies, cleanliness and organization.• Trained new personnel and provided technical assistance.• Enforced GLP’s while overseeing the entire laboratory.