Quality Assurance Medical

BRUCE J. SMITH

** ***** ******, ***** *********, MA / 508-***-****

SUMMARY

Quality Assurance oversight of CHO cell culture Upstream and Downstream manufacturing operations: Working

Cell Bank, Thaw, Spinner Inoculum Train, Seed Bioreactor Train, Perfusion Culture/Media Exchange, Production Culture, Harvest, Clarification Filter Train, Ultrafiltration/Diafiltration I, Protein A Prefiltration, Protein A Chrom-atography, Viral Inactivation and Neutralization, Ultrafiltration/Diafiltration II, Hydroxyapatite Chromatography, DEAE Chromatography, DV50 Viral Reduction, Ultrafiltration/Diafiltration III, Bulk Drug Substance Fill/Freeze,

Drug Fill/Finish

Quality Assurance inspection, physical and functional testing, of the following Class 2/3 medical devices: endo- scopes, arthroscopes, catheters, angioplasty and stenting devices, neurological devices, absorbable and non-absorbable sutures, screws, and bone anchors, surgical instrumentation systems, implantable and diagnostic medical devices, fiber optic balloon catheter components and systems, hydrosurgical cutting devices, drug de-livery and interventional devices, medical device prototypes and pilot production, and returned medical devices that failed during surgical procedures

EXPERIENCE

TEGRA MEDICAL 05 /2010 - present

PROCESS DEVELOPMENT QUALITY ASSURANCE TECHNICIAN II

First piece, in-process, final inspection, and functional testing, of Class 2/3 medical device prototypes and pilot

production, used during minimally invasive surgery, drug delivery, interventional therapies, and orthopedic surgical

procedures; First Article Inspections; DHR and documentation review; cGMP manufacturing audits; noncomfor- mance reporting; root cause analysis; CAPA

STD MED 06 /2008 - 04 / 2009

QUALITY ASSURANCE TECHNICIAN

Incoming, in-process, final inspection, and functional testing, of Class 3 hydrosurgical medical devices, used to

simultaneously cut, ablate, and remove, hard and soft tissue during spine, arthroscopic, and wound debridement

procedures; line clearance; labeling and packaging inspections; environmental monitoring; cGMP cleanroom audits; DHR review; inspection and functional testing of orthopedic surgical instrumentation systems

CARDIOFOCUS 01 / 2007 - 06 / 2008

QUALITY ASSURANCE TECHNICIAN

Incoming, in-process, final inspection, and mechanical testing, of Class 3 fiber optic catheter components used for the visualization and treatment of atrial fibrillation; cGMP cleanroom audits and environmental monitoring; line clearance; label and packaging inspections; nonconformance reporting; root cause analysis and CAPA; DHR review; The CardioFocus balloon catheter ablation system is the first to incorporate an endoscope for direct color visual-ization of the pulmonary vein in a beating heart, in real time, without radiation. On March 13, 2007, the Cardio-Focus catheter system was used to perform the first endoscopically-guided laser ablation for atrial fibrillation in the U.S. during clinical trials at St. John’s Health Center, Santa Monica, CA

AMGEN 12 / 2003 - 01 /2007

SENIOR QUALITY ASSURANCE TECHNICAL LIAISON

Perform technical investigations and product impact assessments on drug production deviations for Amgen, Genentech, and Boringer Ingleheim Biopharmaceuticals; document deviation information, root cause, and CAPA, using the TrackWise Quality Management System; Technical Liaison between Amgen QA and upstream/down-stream biopharmaceutical manufacturing; created a CHO Cell Upstream Manufacturing Science PowerPoint presentation and training manual for Amgen Contract Manufacturing Quality Assurance Associates; drug product batch record review and revision; ensure that documentation and production methods are compliant with cGMP/SOP/BLA & FDA regulations; Mfg. audits; gap analysis; consumer complaints; FDA 210 and 211 for biopharmaceuticals

DOW PHARMACEUTICAL SCIENCES 05 / 2002 - 12 / 2003

QUALITY ASSURANCE / CELL CULTURE TECHNOLOGIST

Quality Assurance monitoring of clients’ mammalian cell upstream/downstream biopharmaceutical manufacturing

operations using disposable Wave Bioreactors and Isolator technology; cGMP cleanroom audits; aseptic technique; area clearance; calibration verification; incident reporting; client notification; nonconformance reporting; root cause analysis and CAPA; Phase 1,2,3 clinical trial and commercial biopharmaceutical manufacturing; media/buffer prep.; aseptic seed inoculation; chemical/nutrient additions; operation of seed and production bioreactors using a DCU; sample management; operation of spectrophotometer, pH, and conductivity meters; operate computerized control systems and data acquisition systems; perform CIP, COP, and SIP; equipment preparation and sterilization; inspection and integrity testing of sterilizing filters; OSHA sharps and biohazardous material management; safety committee; CPR

CI MEDICAL 04 / 2001 - 05 / 2002

QUALITY ASSURANCE TECHNICIAN / QUALITY MANAGER

Incoming, in-process, and final inspection, of Class 2/3 implantable and diagnostic medical devices, used to track and measure exact locations within the human body during internal medical procedures; area clearance; inter-departmental audits; nonconformance reporting; root cause analysis; CAPA; MRB; RMA; CofC; complaint inves-tigations; DHR review; responsible for the evaluation and final disposition of medical devices throughout all phases of production; customer contact regarding quality issues; calibrations

MITEK, ETHICON INC. 01 / 1998 - 04 / 2001

SENIOR QUALITY ASSURANCE TECHNICIAN

Incoming, in-process, final inspection, and mechanical testing, of Class 2/3 orthopedic surgical instrumentation

systems, used to surgically secure soft tissue to bone; complaint investigations; perform failure analysis on returned medical devices that were used in surgical procedures; nonconformance reporting; root cause analysis and CAPA; clean room audits; environmental monitoring; labeling and packaging inspections; DHR review; OSHA blood borne pathogens training

SMITH & NEPHEW ENDOSCOPY 06 / 1994 - 01 / 1998

QUALITY ASSURANCE CLEAN ROOM TECHNICIAN

First piece, in-process, final inspection, and mechanical testing, of Class 2/3 endoscopic and arthroscopic medical

devices; in-vitro conditioning and physical testing of bioabsorbable sutures, anchors, and screws, utilized in human

surgical tissue reattachment procedures; nonconformance reporting; root cause analysis; CAPA; area clearance; cleanroom audits; particle counting; evaluation and disposition of returned optical and surgical instrumentation; DSC, FTIR, and moisture analysis of bioabsorbable polymer materials; DHR review; FDA 21CFR820 for medical devices; ISO-9001:2000/13485:2003, cGMP, SPC, GD&T

EDUCATION

PENN STATE UNIVERSITY

Biotechnology Course: Mammalian Cell Culture Methods and Scale-up Strategies 7 / 2004

RHODE ISLAND COLLEGE

Bachelor's Degree, Major: Industrial Technology, Minor: Biology 5 / 1989

ROGER WILLIAMS UNIVERSITY

Courses: Occupational Health and Industrial Hygiene 5 / 1991

CERTIFICATIONS

CERTIFIED MECHANICAL INSPECTOR 3 / 1995

ASQ License: # 05801

CERTIFIED OPERATOR OF ELECTROMECHANICAL AND HYDRAULIC PHYSICAL TESTING SYSTEMS 4 / 1995

Instron

HIGH PRESSURE STEAM SYSTEMS OPERATION 10 / 1984

State of Rhode Island License: # 5934

CGMP AND THE FDA FOR MEDICAL DEVICES, KEN CARRIER CONSULTING 01 / 1998

Smith & Nephew Endoscopy

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