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Kareem Abderazzaq, B.S., MBA, MB (ASCP)CM (617) 922-4202 Summary Over 10 years of success in both research and clinical environments. My diverse experience ranges from molecular laboratory bench work to a variety of managerial and regulatory related responsibilities. Experience Boston Heart Diagnostics, Framingham, MA. June 2012 to Present Clinical Laboratory Manager – PM Shift There are multiple laboratories that process patient samples during the PM shift including the HDL Map and CoQ10 laboratories as well as the Automated Chemistry lab. My responsibilities include: · Overseeing clinical operations involving specialty chemistry techniques such as UPLC, electrophoresis, western blotting and handling radioactive material, as well as indirect oversight of the automated chemistry laboratory. · Administrative responsibilities such as time card approval, performance reviews and scheduling for over 25 employees. · Authoring and reviewing SOPs. · Enforcement of regulatory compliance including document control, meeting laboratory safety requirements and following all other State (MA and NY) and CAP regulatory guidelines. · Facilitating team collaboration and delegation of responsibilities to lead technicians. · Leading department-wide process improvements including process traceability, improved image analysis and improved UPLC instrument daily qualification. · Enforcement and review of nonconformance reports, monthly audits of assay documentation including transfer of results into the LIS and other quality assurance responsibilities. · Participate in interdepartmental regulatory audits including but not limited to GC/MS and clinical chemistry departments. Planned Parenthood League of Massachusetts, Boston, MA. June 2010 to June 2012 Clinical Laboratory Manager Managing this lab has been a great opportunity to restructure the foundation of the lab by defining and achieving goals necessary for clinical operation. Goals and achievements include: · Setting feasible, clear and stringent quality control standards for CT/GC testing. · Validation, implementation and operation of serum hCG immunoassay testing. · Defining, streamlining and improving upon routine operational processes. · Preparing the annual budget for the lab and providing cost analysis for possible new tests. · Establishing a culture of transparency with upper management and defining routes for interdepartmental communication. · Standardizing operational processes, documentation and communication of offsite laboratories. · · · Customizing the Lab Information System (Orchard – Harvest application) to track sample processing and generate indicator reports that assist with process improvement monitoring. Meeting CLIA and MA. state regulatory requirements. Defining and monitoring turn-around-time goals for patient sample processing. Dana-Farber Cancer Institute, Boston, MA. October 2009 to June 2010 Core Laboratory Compliance Specialist This regulatory oriented position provided me with an opportunity to inspect and advise the clinical laboratories to ensure compliance with state and federal regulations as well as the Joint Commission’s standards. Responsibilities include: · Completion of biannual laboratory audits and electronic interface audits. · Assist the billing department with payer prompted investigations. · Collaborate with disease centers to ensure compliance with laboratory testing. · Investigate interdepartmental compliance related problems. Genomic Health, Redwood City, CA. February 2008 to October 2009 Clinical Laboratory Supervisor The leadership nature of this position allowed me to participate in nearly all operational and managerial tasks. Supervisory duties include daily scheduling, time card approval, performance evaluations, compensation, and special concerns including workers compensation. Enforce compliance within the operations of the laboratory. Ensure employee safety while maintaining a favorable working environment. Conduct safety assessments. Authoring safety SOPs and conducting safety SOP training. Evaluating workflow methodology to increase turnaround time without sacrificing quality. Clinical liaison for interdepartmental sample storage team considering issues of sample retention, access, discard, tracking and organization. Participate in and lead within special projects as required and needed. In addition to my administrative roles, I also was responsible for ensuring completion of numerous technical tasks that include: Extraction of RNA from paraffin embedded tissue RNA quantitation using fluorescence Reverse transcription and qPCR Kaiser Permanente, San Jose, CA. June 2000 to February 2008 Molecular Technologist III The clinical environment of this lab insisted on absolute perfection in duty, complete documentation of every process enforced by government regulation (CLIA), training of new employees and taking proactive measures to secure employee safety. The technical duties of this position included: · DNA extraction from blood, direct and cultured amnios, tissue samples and chorionic villi · RNA extraction from blood and bone marrow · Multiplex and heteroduplex PCR and RT-PCR for our BCR-ABL test · Agarose, acrylamide and capillary electrophoresis · DNA hybridization techniques such as southern blot, PCR transfers and reverse dot blots · DNA labeling for array-CGH · Restriction Enzyme digests Experience with laboratory automation include: · Use of the Qiagen Bio-robot, Biomeck 2000, Biomeck FX, the Hydra dotting system and the 3130 Genetic Analyzer. · Creation of user-friendly methods on the Biomeck FX- “Third-wave” program. · Participated in routine backups of our computer systems. Apart from clinical testing, I was exposed to many other significant administrative areas. Memberships and Participation include: · Member of the Molecular Genetics labor management committee (LMP) · Member of the Genetics Work Place Safety team · Chemical Safety Sub-Committee · Kaiser Permanente Green Team. Harvard School of Public Health, Boston, MA. April 1999 to May 2000 Research Assistant As a new laboratory, this position required great organizational skills and the ability to multi-task. My responsibilities included ordering of laboratory materials and disposables, maintaining and scheduling calibration for equipment in addition to my primary research responsibilities, which permitted interaction with neighboring laboratory staff on a routine basis due to, shared laboratory space and equipment. Furthermore I attended multiple training sessions in chemical and biological related safety. Technical duties included: · Ordering of primers · PCR extraction from agarose gels · Preparation of agar plates · Restriction digests · Cloning of E.coli, S.cerevisiae and S.pombe · Protein expression UMass Medical Center, Worcester, MA. May 1998 to August 1998 Research Intern Participated in protein structure analysis research using X-ray crystallography and computer imaging software on earthworm hemoglobin. Most common techniques used in this project were protein isolation and crystallization, spectrophotometric readings and X-ray defraction. White Hen Pantry, Worcester, MA. January 1994 to April 1999 Assistant Manager Part time position affording opportunity to engage in managerial tasks such as weekend scheduling, preparation of orders, material preparation, staff training and task assignments. Education University of Phoenix, San Jose, CA. 2006 M.B.A., Healthcare Administration (On-campus and online hybrid program.) University of Massachusetts, Amherst, MA. 1999 B.S., Biochemistry, Minor: Food Science Other non-degree courses include Practical Approaches to Quality Control, Statistical Methods for Clinical Laboratorians and Clinical Laboratory Leadership and Management from AACC. Computer Skills • LIS applications including Orchard Harvest, Sunquest and Seacoast. • MasterControl, a laboratory document control application. • Advanced experience with Microsoft Word, Excel, PowerPoint, Outlook, Access, Internet Explorer and familiar with MS Project. • Health information application experience include the Integrated Genetics System “IRGS”, Health Connect, GEMTools, LabExplorer, CRM, GE-IDX, Crystal Enterprise Launchpad, CAS and LMR. • Other applications include Livelink, Sharepoint, People Soft, Mac OS X, Motion, iLife software, Adobe Photoshop, Macromedia Dreamweaver and Flash and fair knowledge of the C programming language. Publications "Mitochondrial origin by sulfur symbiosis." From Symbiosis to Eukaryotism Endocytobiology VII, January 1999, 8p "Combinatorial diversity of fission yeast SCF ubiquitin ligases by homo- and heterooligomeric assemblies of the F-box proteins Pop1p and Pop2p." BMC Biochem, August 2002, 46p Licensure & Affiliations · · Laboratory Technologist in Molecular Biology certified by ASCP. Member of ASQ and AACC