Christine Scheaffer
Quality Assurance Auditor-GLP at MB Research Laboratories- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Jordyn L.
Christine Scheaffer has managed our on-site Quality Assurance program, internal auditing, and maintained compliance with FDA regulations for the last 7 years. She maintains excellent records and has led our facility through several FDA, EBAA, and state inspections all with no non-conformities. Christine is detail-oriented and has extensive Quality experience with several years of additional focus in the medical device and transplant tissue fields. Christine is a wealth of knowledge when it comes to interpreting regulations and requirements and has again and again proven the ability to guide a clinical team through changes in regulations; then to apply and abide within them in real-world clinical situations. Christine is meticulous and timely with all facility records, equipment verification, and maintenance. If given the opportunity to work with Christine again in the future, I would without hesitation. She is a hard worker, an exceptionally valuable team player, and has a keen eye that will without a doubt help her next team thrive. Feel free to reach out if you have any questions. Holly Lorentz, BA, CEBT Distribution Services Lead CorneaGen
Kristen Heller
Although Christine was not my direct report, I have had the opportunity to observe her skills and work closely with her on several projects along with day to day operations of the laboratory. Christine has proven to be a dependable employee and a hard worker. She is a team player that has the ability to work with minimal supervision. She has done an exceptional job as the sole QA representative at our location preparing and passing our FDA and EBAA inspections. It is with confidence that I would recommend her very detailed Quality Assurance skills. I believe that Christine would be an excellent addition to any team.
Jordyn L.
Christine Scheaffer has managed our on-site Quality Assurance program, internal auditing, and maintained compliance with FDA regulations for the last 7 years. She maintains excellent records and has led our facility through several FDA, EBAA, and state inspections all with no non-conformities. Christine is detail-oriented and has extensive Quality experience with several years of additional focus in the medical device and transplant tissue fields. Christine is a wealth of knowledge when it comes to interpreting regulations and requirements and has again and again proven the ability to guide a clinical team through changes in regulations; then to apply and abide within them in real-world clinical situations. Christine is meticulous and timely with all facility records, equipment verification, and maintenance. If given the opportunity to work with Christine again in the future, I would without hesitation. She is a hard worker, an exceptionally valuable team player, and has a keen eye that will without a doubt help her next team thrive. Feel free to reach out if you have any questions. Holly Lorentz, BA, CEBT Distribution Services Lead CorneaGen
Kristen Heller
Although Christine was not my direct report, I have had the opportunity to observe her skills and work closely with her on several projects along with day to day operations of the laboratory. Christine has proven to be a dependable employee and a hard worker. She is a team player that has the ability to work with minimal supervision. She has done an exceptional job as the sole QA representative at our location preparing and passing our FDA and EBAA inspections. It is with confidence that I would recommend her very detailed Quality Assurance skills. I believe that Christine would be an excellent addition to any team.
Jordyn L.
Christine Scheaffer has managed our on-site Quality Assurance program, internal auditing, and maintained compliance with FDA regulations for the last 7 years. She maintains excellent records and has led our facility through several FDA, EBAA, and state inspections all with no non-conformities. Christine is detail-oriented and has extensive Quality experience with several years of additional focus in the medical device and transplant tissue fields. Christine is a wealth of knowledge when it comes to interpreting regulations and requirements and has again and again proven the ability to guide a clinical team through changes in regulations; then to apply and abide within them in real-world clinical situations. Christine is meticulous and timely with all facility records, equipment verification, and maintenance. If given the opportunity to work with Christine again in the future, I would without hesitation. She is a hard worker, an exceptionally valuable team player, and has a keen eye that will without a doubt help her next team thrive. Feel free to reach out if you have any questions. Holly Lorentz, BA, CEBT Distribution Services Lead CorneaGen
Kristen Heller
Although Christine was not my direct report, I have had the opportunity to observe her skills and work closely with her on several projects along with day to day operations of the laboratory. Christine has proven to be a dependable employee and a hard worker. She is a team player that has the ability to work with minimal supervision. She has done an exceptional job as the sole QA representative at our location preparing and passing our FDA and EBAA inspections. It is with confidence that I would recommend her very detailed Quality Assurance skills. I believe that Christine would be an excellent addition to any team.
Jordyn L.
Christine Scheaffer has managed our on-site Quality Assurance program, internal auditing, and maintained compliance with FDA regulations for the last 7 years. She maintains excellent records and has led our facility through several FDA, EBAA, and state inspections all with no non-conformities. Christine is detail-oriented and has extensive Quality experience with several years of additional focus in the medical device and transplant tissue fields. Christine is a wealth of knowledge when it comes to interpreting regulations and requirements and has again and again proven the ability to guide a clinical team through changes in regulations; then to apply and abide within them in real-world clinical situations. Christine is meticulous and timely with all facility records, equipment verification, and maintenance. If given the opportunity to work with Christine again in the future, I would without hesitation. She is a hard worker, an exceptionally valuable team player, and has a keen eye that will without a doubt help her next team thrive. Feel free to reach out if you have any questions. Holly Lorentz, BA, CEBT Distribution Services Lead CorneaGen
Kristen Heller
Although Christine was not my direct report, I have had the opportunity to observe her skills and work closely with her on several projects along with day to day operations of the laboratory. Christine has proven to be a dependable employee and a hard worker. She is a team player that has the ability to work with minimal supervision. She has done an exceptional job as the sole QA representative at our location preparing and passing our FDA and EBAA inspections. It is with confidence that I would recommend her very detailed Quality Assurance skills. I believe that Christine would be an excellent addition to any team.
Experience
-
MB Research Laboratories
-
United States
-
Research Services
-
1 - 100 Employee
-
Quality Assurance Auditor-GLP
-
Aug 2020 - Present
-
-
-
CorneaGen
-
United States
-
Hospitals and Health Care
-
100 - 200 Employee
-
Quality Assurance & Regulatory Affairs Coordinator
-
Mar 2013 - Oct 2019
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. Show less
-
-
-
Eberline Services
-
United States
-
Environmental Services
-
1 - 100 Employee
-
Quality Assurance Analyst
-
Sep 2010 - Jul 2012
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. Show less
-
-
-
Teleflex
-
United States
-
Medical Equipment Manufacturing
-
700 & Above Employee
-
Quality Assurance Laboratory Technician
-
Jul 2007 - Sep 2010
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. Show less
-
-
-
Kensey Nash Corporation
-
Exton, PA
-
Sr Biomaterials QC Technician
-
Dec 1999 - Dec 2006
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. Show less
-
-
Education
-
Montgomery County Community College
Associate of Science - AS, Biological Sciences
Community
