Laboratory manager
Resume:
CURRICULUM VITAE
Javed I. Khan,
Corona CA 92879
951-***-**** (cell)
acz3tc@r.postjobfree.com
Licensed CLS (Chemistry) LFS California Department of Public Health Certified Clinical Chemist (ASCP)
Certified Quality Auditor (Exemplar Global)
Licensed Forensic Investigator: (California BSIS)
Expertise:
Managed/Audited/Inspected pharmaceutical, toxicological, clinical, and genomic laboratories, healthcare and educational institutions for CLIA, COLA, ISO, CAP, DEA, FDA, ICH, AABB accreditation, inspection, recertification and or deficiency responses.
Wrote IQ/OQ/PQs, SOPs, TPs, safety and QA/QC manuals for pain management, pharmaceutical, forensic, genomic, and clinical (low, medium, and high complexity) laboratories, healthcare and educational institutions.
Developed, validated, and updated analytical methods for LCMS, GCMS, ELISA, HPLC and other instruments.
Developed, updated, and implemented training material and trained newly hired analytical/non-analytical laboratory staff.
Performed the examination, successfully completion, and reporting of CAP, AAB, ABB, DOT, ASCLAD and API proficiency tests for medium/high complexity Forensic, Clinical, and Toxicological Laboratories. Degrees:
- University of California Riverside, Masters of Science, Biochemistry/Molecular Biology, 1994
- University of Agriculture Faisalabad, Pakistan, Masters of Science, Biochemistry (Major), Microbiology
(minor), 1982
- BZ University Multan, Pakistan, Bachelor of Science of Science, Chemistry/Biology, 1980 Certifications
o CLS (Chemistry) LFS California Department of Public Health (MTC 01010138) o C(ASCP): Certification # 4849
o QMS Lead Auditor: ISO-9001-2008 (TPECS) Certification o Medical Devices Quality Lead Auditor: ISO-13485 (TPECS) Certification o Testing and Calibration Laboratories Lead Auditor: ISO/IEC-17025 (A2LA) Certification o Clinical/Medical/Genetics Laboratories Lead Auditor: ISO/IEC-15189 (PLJA) Certification o Exemplar Global: Certification # 129188
Professional Education (Received/Given)
o Teaching Member of Advisory Board for Clinical Laboratory Scientist (CLS) and Clinical Laboratory Assistant (CLA) at Dixie State University, St. George Utah. o Drug Testing for Pain Managements Clinics: Extensive Experience in training CLS for testing drugs for pain management clinics.
o Analytical: Expert analyst for Drugs of abused, Toxicology and Alcohol analysis, Serology and Body Fluid Identification, and Advanced Drug Analysis, Case Approach to Biological Evidence {California Criminalisitic Institute (CCI) Certifications}
o Instrumentation: Expert operator, maintainer, and trainer of LCMS QQQ, LCMS, GCMS, FTIR, IR, Intoxilyzer, Headspace -MS, Fuel Cell Technology, HPLC, Abbot Architect CI and Cell Dyne and more
(California Criminalisitic Institute (CCI) Certifications and Agilent technology Certifications) Resume of JIK Page: 2 of 4
Professional Experience:
Manager Laboratory Operation: SDXRAY Medium Complexity Clinical Laboratory, Santee, CA: Jan. 2017-Current: (contract assignment).
Run day-to-day operation of the clinical laboratorytion such as staff scheduling, personnel, purchasing, monitoring the QA/QC of the instruments and patients’ test result. Managing all aspects of the laboratory including but not limited to CLIA, COLA, CAP compliance for audit, recertification and deficiency responses. Identify non-conformities and implemented regulatory compliances for actual inspection. Developed, validated, and updated various analytical methods that managed laboratories' expansion.
Office of the Attorney Journal, State of Utah, Child Protective Division; Toxicological, Chemical, and Forensic Consultant: 2015-Preesent (contract assignment)
Laboratory Manager: Intermountain Healthcare, Dixie Regional Medical Level II Trauma Center and 300- Bed Hospital, St. George, UT: January 2015-2016 Manage Blood Bank, Andrology, Chemistry, Histology, Toxicology, Hematology, Microbiology, Cytology, QA/QC, and Phlebotomy Sections of the Laboratory. Job responsibilities include but not limited to the following:
Responsible for Lab performance and compliance with patient safety initiatives, federal, state, and other regulatory bodies including CLIA, CAP, The Joint Commission, OSHA, CMS, DOPL and other department specific accrediting and certifying bodies.
QC/QA Manager: ALCALA Pain Management High Complexity Clinical Laboratory, San Diego, CA: September, 2011- June, 2014: (contract assignment). I started this high complexity lab from the ground up. I developed and validated analytical methods for LCMS, and other instruments. Following ISO/IEC-17025 guidelines, I prepared the laboratory for CLIA and COLA inspections and recertification. Identified non-conformities and implemented compliance. I examined, successfully completed, and reported CAP and API proficiencies tests. I became the certified operator, maintainer and trainer of LCMS-QQQ and LCMS. I developed and implemented training program for the laboratory, trained, and documented training of newly hired technical/non-technical staff.
QC/QA Internal Auditor/Quality Manager: GenWay Biotech, INC, Proteins and Antibodies Solution, San Diego, CA: June 2014- December 2014(contract assignment). Following ISO-9001:2008 and ISO-13485 guidelines, audited the laboratory for pre-CLIA, COLA, ISO, CAP, FDA, DEA, inspections, recertification and deficiency responses. Identified non-conformities and implemented regulatory compliances. Developed, validated, and updated various proteins and antibodies syntheses methods that helped laboratory's expansion. Updated and implemented SOPs, TPs, safety and QA/QC manuals for GCP, cGMP, and GLP USP, EUP, ICH for America, Europe, and International. Updated and implemented training program for the laboratory, trained, and documented training of newly hired technical/non-technical staff.
Professional Experience Continues:
Set the strategic direction for the Laboratory, including short and long-term objectives, goals, and success measures.
Develop and oversee financial plans including operating and capital budgets and meeting established budget objectives. Identifies and explains budget variances and adjusts the budget as needed. Manages controllable / approved volume adjusted subtotal expense budget, volume adjusted FTEs, fix department NOI, and region NOI.
Create Lab department goals and analyzes department needs while integrating with hospital / region annual goals and department vision to provide optimal care and service to patients.
Oversee the effective management of human resource programs and ensures a competent staff. Coaches and mentors Lab leadership team and direct reports.
Ensure achievement of Lab programs and support service goals. Monitors and improves patient and client satisfaction utilizing available service metrics and national benchmarks. Resume of JIK Page: 3 of 4
QC/QA Internal Auditor/ Quality Manager: Crestview High Complexity Clinical Laboratory, Santee, CA: December 2013- December 2014: (contract assignment).
QC/QA Internal Auditor/ Quality Manager: SDXRAY High Complexity Clinical Laboratory, Santee, CA: December 2013- December 2014: (contract assignment).
QC/QA Internal Auditor/ Quality Manager: Synergy Hematology High Complexity Oncology Medical Associates Laboratory, Beverly Hills, CA: April 2014 –December 2014: (contract assignment). Managed all aspects of the above medium complexity laboratories: Following ISO/IEC-17025 guidelines- I pre-inspected these labs for CLIA, COLA, CAP audit, recertification and deficiency responses. Identified non-conformities and implemented regulatory compliances for actual inspection. Developed, validated, and updated various analytical methods that managed laboratories' expansion. Examined, successfully completed, and reported CAP, API, and AAB proficiencies tests. I updated and implemented SOPs, TPs, safety, and QA/QC manuals for GLP/GCP. Developed and implemented training programs, trained, and documented training of newly hired technical/non-technical staff.
Forensic Scientist (Retired) California State Department of Justice, Bureau of Forensic Services, Riverside: Criminalistics Laboratory: September, 1989- August 2011: (Retired) Worked in this lab for twenty-two years and became a certified operator, maintainer and trainer of instruments like GCMS, FTIR, IR, Intoxilyzer, Headspace-MS, Fuel Cell Technology and other instruments. Participated in the development and validation of Analytical Methods on the above, and other instruments. Certified analyst and trainer for Drugs of abused, Toxicology, and Alcohol analysis, Serology and Body Fluid Identification, and Advanced Drug Analysis, Case Approach to Biological Evidence. Following ISO-17025 guidelines, participated in the laboratory for ASCLAD and ISO inspection, accreditation, and certification processes. Helped resolved the identified non-conformities and implemented compliance. Examined, successfully completed, and reported ASCLAD/DOT/ISO/CCI proficiencies tests. Trained and documented training of newly hired technical.
Adjunct Faculty (Retired)
Chemistry/Forensic Chemistry: Southern California University, Integrated Science Program, Riverside Com. College/Mt. San Jacinto College/Victor Valley College, 1994 – 2012: (retired) Experience in Developing Training and Course Curriculum
Developed training curriculum and course curriculum for colleges and laboratories staff. Experienced Trainer
Trained newly hired CLS/CLA- SOPs, TPs, the theory and interpretation of Abbott CI8200, CI4100, Head Space GC, GCMS, HPLC, LCMS (QQQ), IR, FTIR, Visible Spectrometer, ELISA, RIA, and other instruments used in Clinical/Pharmaceutical/Diagnostic/Genetics/Forensic Laboratories. Courtroom Presentation of Forensic Evidence Experience
I have testified as an Expert Witness in numerous Federal, State, and Local Courts of Law in the USA for over 500 times during the last 21 years work experience with DOJ. Resume of JIK Page: 4 of 4
Publications:
-Coauthored a College/University Textbook:
“Basic Principles of Forensic Chemistry”
Published by Springer Publications in January, 2012. www.springer.com
“Analysis of Drugs of Abuse from Hair” Tieline: Publication of Department of Justice, State of California
(1990)
“Studies on the Incidence of Penicillin Resistance Against Staphylococci” Pakistan Journal of Medical Research, (1984)
“Incidence of Penicillin Resistance Against Staphylococci” Pakistan Journal of Veterinary Sciences (1984)
-References Furnished Upon Request
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