Curriculum Vitae

Name: Caryn K. Mack

Home Address: **** ** *** ****

Cooper City, FL 33330

Cell: 908-***-****

E-mail address: aduoyr@r.postjobfree.com

Work Address:

Citizenship: USA

Education

B.A. Biology/Microbiology State University of New York at Plattsburgh, N.Y.

M.S. Medical Biology, C.W. Post Center, Long Island University, Greenvale, N.Y.

Clinical Rotations: North Shore University Hospital/Cornell University, Manhasset NY

Work Experience

3/14-1/22 Spectra Laboratories

525 Sycamore Dr.

Milpitas, CA 95035

Director of Quality Systems and Regulatory Affairs

Duties: Coordination of all state and regulatory licenses including inspections: Joint Commission, CAP, ISO 15189, California, New York, Florida, Pennsylvania, Rhode Island, Maryland and NYELAP.

Oversight of all Quality Systems including electronic document storage, software upgrades testing, safety, including OSHA regulations. New employee orientation for blood borne pathogens, chemical hazard and general safety.

Interact with technical staff on a daily basis

All proficiency testing and investigations.

Oversight of the monthly Quality Counsel Review

Non-Conformance committee member

Hematology and Chemistry Quality working groups

Interact with QA staff and others from our sister labs in NJ and MS

Training for GCP and PI for studies and research projects

Direct Reports: 5

8/09-2/14 Quest Diagnostics

967 Mabury Rd

San Jose, CA 95133

Operations Supervisor, RRL laboratories/ Technical Supervisor Hematology/ Manager, Main lab in San Jose

Duties: oversight of 5 stat labs in the Fremont to Salinas area. Quality Assurance and Compliance, scheduling and daily operations, including one lab that services an ambulatory urgent care center that is 365 days/year.

Direct Reports: 8 FT, 4 PT

Six Sigma Green Belt Training- Coagulation work cell lean, Closure of McKee RRL.

Corporate evaluation and validation of Beckman Coulter DhX800 hematology system

Interfaced all automated systems at all 6 labs

Leadership Development Program participant

Technical Supervisor, Hematology 10/12-2/14

Manager San Jose Laboratory 3/13-2/14 all technical departments and approximately 150 employees

3/09-8/09 Institute of Medical Education

130 Almaden Ave

San Jose, CA 95113

Director, MLT Program

Summary of duties: Design and implement a Medical Laboratory Technician education program. Set up internship sites, develop budget, purchase equipment, speak to perspective students and externship sites. Develop lecture, testing and laboratory material. Teach classes.

10/06-2/2009 Manager: Camino Division Laboratory, Palo Alto Medical Foundation Mountain View, CA

Summary of Duties: Oversight of da to day operations for a large outpatient laboratory including quality control and CQI, inventory, and scheduling. Lab testing volume is in excess of 2 million tests per year. Oversight of an off-site stat lab and point-of-care testing. Laboratory runs 18 hours/day, 365days/year. Technical bench work when

needed. Number of employees: 9 full-time and 6 part-time direct reports. Total employees in lab: 53

10/ 95- 10/06 Manager: Reproductive Endocrinology and Basic Andrology Laboratory, Institute for Reproductive Medicine and Science, Saint Barnabas Medical Center Livingston, NJ

Summary of Duties: Managerial and technical oversight of the reproductive endocrine and basic andrology laboratory as well as all phlebotomy and esoteric testing. Quality assurance and CQI for the laboratory including CLIA and State licensing. FDA oversight team for egg donation. Assist in research projects for OB-Gyn residents. Training for PI for patient studies. Number of employees: 3 full-time, 2 part-time

8/93-8/95 Clinical Laboratory Supervisor: Reproductive Science Center of the Bay Area, San Ramon, CA

Summary of Duties: Designed and implemented physician office laboratory including phlebotomy and reference testing. Complete oversight of QA, and CLIA compliance. Patient chart reviews for SART statistics keeping. Number of employees: 4 part-time

Certifications and Licensing

ASCP MT #122804

California MT #MTA-00032632

Publications and Abstracts

Seifer DB, Scott RT Jr, Bergh PA, Arbogast LK, Friedman CI, Mack CK, Danforth DR; “Day 3 Serum Inhibin-B May be the Earliest Indication of Diminished Ovarian Reserve in Women Undergoing ART “; abstract ASRM 1997

Scott RT Jr, Adler R, Mack R, Mack C, Smith T, Brenner CA, Walmsley R, Reing A, Bergh PA ;” Peripheral Natural Killer (NK) Cell Levels and other Peripheral Lymphocyte Subsets (Reproductive Immunophenotype) do not Prognosticate IVF Pregnancy Rates or Outcome “; abstract ASRM 1998

Seifer DB, Scott RT Jr, Bergh PA, Arbogast LK, Friedman CI, Mack CK, Danforth DR; “Women with declining ovarian reserve may demonstrate a decrease in serum inhibin-B before a rise in day 3 follicle stimulating hormone”; Fertility and Sterility 1999 Jul;72(1):63-5

Alikani M, Cohen J, Tomkin G, Garrisi GJ, Mack C, Scott RT Jr.;” Human embryo fragmentation in vitro and its implications for pregnancy and implantation”; Fertility and Sterility 1999 May; 71(5):836-42

Chen S, Mack C, Cekleniak N, Garrisi M, Schramm A, Sable D "Gnrh antagonists and Poor responders: Is there hope after a failed microdose agonist flare cycle?" Poster presentation at the 59th annual meeting of the American Society for Reproductive Medicine(ASRM) October 2003, Seattle WA.

Mack C, Chen S, Porudominsky-Weitzman V, Cekleniak N, Sable D: "Stability of day 3 FSH levels in relation to various transport container and heat stress" Poster at annual meeting for the American College of Obstetrics and Gynecology (ACOG) 2004, Philadelphia PA.

Ericsson D, Mack C, Cekleniak N, and DeSilva M

Interleukins and Insulin-Like Growth Factors in IVF Patients- Senior research day –SBHCS 2005

.

Chen SH, Mack C, Colls P, Kasdaglias T, Garrisi M, Munne S. "PCO and high

responders have higher rates of aneuploidy by PGD." Poster presentation at the 61st

Annual Meeting of the American Society for Reproductive Medicine (ASRM) October

2005, in Montreal, Canada.

MackC.,Anglade,C.,DeSilva,M.,Cekleniak,N,.Garrisi,M,andChen,S"Change in estradiol-17β (E2) level after hCG is predictive of pregnancy outcome in IVF patients".-Poster presentation at the 61st Annual Meeting of the American Society for Reproductive Medicine (ASRM) October 2005 Montreal Canada

Mack,C., Pascale,C.,Gupta,N.,Chen,S.,Cekleniak,N.,Garrisi,M “In Search of the Perfect Donor-BMI and Egg Donation”- Poster presentation at the 62nd Annual Meeting of the American Society for Reproductive Medicine (ASRM) October 2006, New Orleans LA.

Mack C.,Sun J. Gamie,I, Pearce,J,Burdick C. “Is the Quality of Water Testing Affected by the Shipping Temperature of the Specimen?” Poster presentation at Lab Quality Confab, October 2019, Atlanta GA.

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