Laurie Huff, Csqp (Asq), Cqa (Asq) Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Raleigh-Durham-Chapel Hill Area

North Carolina, United States

Raleigh-Durham, North Carolina Area

Durham, Nc

Responsible for the oversight of key tactical, functional, and operational aspects within Quality Assurance • Conduct internal and supplier audits • Develop audit plans/schedules with statistically based binomial sampling plans using a risk based approach• Responsible for supplier management programs • Review of GMP data and records for compliance, review and approval of GMP investigations• Lead and participate on site CAPA teams, review and approval of procedures, protocols, and reports, develop and perform Quality systems training • Identify gaps in existing Quality systems and propose recommendations to site management, perform trending and analysis for site nonconformances, and prepare metrics for Quality Site Management Review. • Assist in the development and implementation of global and site Quality Systems• Provide oversight for the administration and adherence to policies and procedures• Manage projects and Quality initiatives, oversee adherence to regulatory regulations, interface with internal customers and Senior Management• Provide coordination, oversight, and leadership of nonconformance and CAPA investigations

Jessup, Pa

• Responsible for the verification of MTFs quality system, ensuring it is established, implemented & maintained in compliance with applicable government regulations (21 CFRs, ISO 13485, Canadian CMDCAS, standards of the American Association of Tissue Banks & other industry standards)• Plan, perform, report & follow up on internal audits & supplier audits, GMP service providers, etc. & other external organizations to ensure procedural, standards & regulatory compliance (cGMP, QSR, GTP, ISO, CMDCAS & AATB Standards)• Perform supplier qualification audits, write reports, follow up letters & other communications• Issue, track & report status updates for internal audit responses, CAPAs, supplier questionnaires, supplier audit responses & quality agreements • Provide support, communications & coordination with regulatory bodies during inspections & for responses & follow up• Represent MTF on matters of quality with QA personnel, other departments within MTF, procurement agencies, & suppliers of goods/services used in tissue & medical device processing & distribution• Provide audit reports, trend analysis, nonconformances, complaints, etc to management for inclusion in decision making processes• Identify, investigate & report nonconformances related to processes or products• Assist in trend analysis of environmental data, nonconformances, complaints, & production releases/reworks/rejects• Compose & revise QA SOPs, specifications, validation procedures, work instructions & forms. Assists other departments with procedure controls as requested• Quality reviewer/approver on documents, change controls, CAPAs & validations• Provide training support on quality assurance & regulatory affairs topics• Assist on special projects such as software testing. Author instructions for software use, design & perform training for compliance related software (i.e. InfoCAPA 9i)

Swiftwater, Pa

Performed process validation in various areas of viral vaccine production. Including writing, executing and summarizing studies such as APS's, hold time and mixing validations.

Swiftwater, Pa

Performed various ELISA testing on pre-clinical samples for various products. Responsibile for equipment qualification, capital equipment purchases, laboratory inventory and ordering.

East Stroudsburg, Pa

Supervised second shift technologists (approximately 7 direct reports), laboratory secretaries and phlebotomists Responsible for staffing & clinical operations of all areas of the laboratory including clerical, phlebotomy & technical aspects of second and third shift testing. Performed testing in all departments of the laboratory including microbiology, hematology, coagulation, chemistry, serology, immunology & blood bank performing manual & automated tests. Trained in principles of multiple types of technology contained within instrumentation including flow cytometry.

Shawnee On Delaware, Pa

ADMINISTRATIVE DUTIES: Assisted in identifying areas where training is needed. Developed & presented clinical training materials to office RN’s, LPN’s & MA’s including proper documentation training. Complete insurance referrals & ensure all regulations are followed. Designed, developed & implemented referral/insurance manual in reference to specific test coverage based on specific insurance company. Conducted training sessions for insurance referrals. Assisted providers in special projects & studies. Ordered medical & lab supplies, ICD-9 coding, CPT coding. Processed & scheduled all outside appointments & consultations.LABORATORY DUTIES: Redesigned and redefined laboratory testing. Rewrote procedures and policies as indicated. Re-established quality control and quality assurance practices. Conducted laboratory training of all medical staff. Processed & tested specimens for hematology, chemistry and microbiology. Performed phlebotomy.CLINICAL DUTIES: Document patient vital signs & complaints. Assist in minor surgical & routine office procedures. Administer breathing treatments, 10-Lead EKG’s, audiograms, tympanograms, 24-hour holter monitors. Assist providers in special clinical trial projects/studies

Bachelor Of Science (Bs), Clinical Laboratory Science/Medical Technology/Technologist

Activities and Societies: Women's Soccer, Theatre, Alpha Psi OmegaInternship - Scranton Medical Technology Consortium - Award - Most.

Bachelor Of Science (B.S.), Clinical Laboratory Science/Medical Technology/Technologist