Manager Medical

Patricia R High-Edo

*************@*****.*** 857-***-****

Malden, MA 02148

SUMMARY

Experienced Technical Supervisor/Manager knowledgeable about leading teams, managing projects and coordinating program resources. Offering 25 years of Laboratory experience along with a proven safety record, performance-oriented nature, strong history of accomplishment, advanced communication and problem-solving abilities. Ready for new professional challenges and career advancement. I will bring 12 years of leadership experience to this challenging new role with long-term potential and advancement.

SKILLS

Calibration

Chemistry

CLIA

Compliance

FDA

Hematology

Inspection

ISO/IEC 17025

Internal Audits

Laboratory equipment

Laboratory testing

Personnel

Policies

Quality Assurance

QA

Quality Control

Research

Safety

Surveys

Technical support

Validation

EXPERIENCE

Documentation and Audit Consultant

Ginkgo Bio Works-Atrium Staffing

July 2020-present

Start-up Covid-19 Lab

Regulatory and Quality documentation

QAQC team member - Media Lab audits

CLIA Regulations and Audits

Defining the audit protocols ( what to audit, frequency, checklist and the objective)

Findings - CAPA, QE, Validation, Process and Change Control

Internal audits - Concentrics & Assessments

Walkthrough Lab audits (inspection)

Mock audits with in the ConOps lab

Training audits - making sure training is performed

Audit, compliance and SOP reviews

Monitor operations to assure compliance and regulatory goals are developed

Clinical laboratory supervisor -Molecular Microbiology COVID-19 testing- July-September 2020

Consultant-Medical

Guidepoint Global Contract

April 2020 - Current

60-90 minutes consultation

Covid-19 consults

Laboratory consults, planning and testing modules

Quality consultant

Technical Supervisor - Manager

Elm Tree Clinic - Quincy and Lowell Quincy, MA October 2018 - Current

Technical supervisor for toxicology lab and LC-MS labs.

Manage 2 staff Medical Scientist and 10 Medical Assistants.

Maintained validation data and ISO 17025 quality data.

Devised strategies for optimizing work procedures, technical training and standard processes.

Evaluated and reviewed staff performance.

Generated reports outlining latest updates, results and proposed solutions.

Determined proper allocation of resources to maximize work coverage and team effectiveness.

Inspected completed work to assess quality and identify skill or ability issues.

Eliminated knowledge gaps by managing continuous training and mentoring strategies for new and junior personnel.

Medical leave from full time work 12/ 2019-7/2020

Laboratory Operations Admin

PerkinElmer - Amgen Cambridge, MA September 2018 - April 2019

Act as a conduit between functional areas and various units.

Monitored and maintained the freezer farm alarms systems.

Work with scientist on locations, moves of laboratory equipment and space.

Initiate and manage work orders.

Manage equipment installs and reinstall.

Provided excellent service and attention to customers when face-to-face or through phone conversations.

Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.

Improved operations by working with team members and customers to find workable solutions.

Retail Secret Shopper

August 2018 - Present

Secret shopping in high end stores.

Perform according to assignments

What the store associate interaction with the customer

She how the store offers a discounted offer

Follows a scenario

Perform a written evaluation

Clinical Laboratory Manager

Codman Square Health Center Dorchester, MA July 2016 - January 2018

Executed daily operations of the laboratory.

Lab Project Manager - Outreach Program for HIV Testing Multisite program. Application process and accreditation from DPH.

Maintained proficiency and validation for all designated LIS functions (Orchard Harvest and EPIC).

Graduate Orchard Harvest LIS Advanced User Program.

Worked closely with team members to deliver project requirements, develop solutions and meet deadlines.

Workflow mapping for Orchard & Epic systems.

Coordinated with director of performance improvement and evaluated all improvement activities.

Implemented new tests, purchasing new equipment, ordering supplies.

In conjunction with the laboratory Medical Director, develop, update, and implement policies and procedures for the laboratory and implements necessary measures to ensure JCAHO, CLIA, OSHA and state regulation compliance.

Improved profit margins by streamlining operations and workflow and negotiating competitive vendor contracts.

Managed POCT glucose program, install new software, implements standards and regulatory upgrades.

Spent 4 hours a day on the bench covering for 2nd shift staff.

Trained instrumentation: Hematology - Sysmex 1000i, Siemens CA-540, Clintek Advantus & Status, Urine Sedimentation.

Chemistry- Centaur XP, Dimension EXL.

Molecular-GC/CT Viper LT.

Blood Bank Supervisor

Blood Bank, St. Vincent Hospital - LabCorp Worcester, MA September 2014 - July 2016

Executed daily operations of the blood bank.

Upgrade current Mediware-HCLL user program.

Directed and advised personnel in special testing procedures and performed reference laboratory testing.

Hired, trained and managed employees, set schedules and improved performance.

Wrote, designed and implemented new procedures and policies.

Part of the Quality (QA) and Safety implementation team.

Analyzed and managed quality assurance records for compliance purposes.

Supervised and managed a staff of 8.

Implemented new tests, purchasing new equipment, ordering supplies.

Conducted and maintained CAP surveys and ensured the Technologists had adequate continuing education material to be proficient in their job.

Successfully completed and passed CAP, and AABB inspections 0 non-conformance and 0 recommendations.

Successfully completed courses in laboratory inspection for CAP.

QC Specialist / Blood Bank Section Startup Project Manager

Quest Diagnostics Marlborough, MA April 2011 - September 2014

Managed Quality Control Quest Cambridge/Marlborough BU.

Monthly: analyzed data and evaluate the current process and change according to the Interlab QC.

Responsible for all levels of QC/QA problems.

Analyzed issues and recommended corrective actions to improve final results.

Monitored & evaluated all QC data daily, weekly and monthly.

Outlined remediation plans to standardize results to meet compliance regulations.

Performed quality control inspections at customer sites to determine alignment with safety regulations.

Assisted in internal Audits and Reviews for all departments.

Reviewed SOPs ensuring they are with the corporate, Camb/Marlborough BU, and regulatory requirements.

Provide technical support during CAP, NQA and DPH inspections.

Team Auditor for Quest-Cambridge.

Audits laboratory sections for CAP, State and NQA prior to inspections.

Consultant / Interim Supervisor Blood Bank section, NEO and Manual Testing (Type and Screens, Antibody ID, DAT, and Antigen testing), supervised 6 employees

Paramedical Examiner

ExamOne Providence, RI December 1994 - April 2011

Evaluated patients' medical status and monitored vital signs during transit.

Documented all patient information, including condition or injury, treatment and medication administration.

Field Supervisor

Performed phlebotomy, EKG, Saliva swabs and collected urines as part of their health evaluation.

Processed and mail kits to Lenexa, KS

Blood Bank Supervisor

Winchester Hospital Winchester, MA February 2008 - March 2010

Executed daily operations of the blood bank.

Supervised and managed a staff of 15

Directed and advised personnel in special testing procedures and performed reference laboratory testing.

Hired, trained and managed FT staff and Travelers employees, set schedules and improved performance.

Wrote, designed and produced new procedures and policies.

Was instrumental in Quality and Safety.

Conducted quality control checks, calibration and technical troubleshooting of Blood Bank Provue analyzer.

Implemented new tests, purchasing new equipment, ordering supplies. Project manager for GrenierOne plastic from glass blood tubes, cost savings 50K,

Applied knowledge of microbiology, chemistry and hematology daily as a site supervisor.

Performed CAP surveys and ensured that the Technologists had adequate continuing education material to be proficient in their job.

Successfully completed and passed CAP, AABB, and FDA inspections at Winchester Hospital.

Successfully completed courses in laboratory inspection for CAP.

Medical Technologist II

Blood Bank, Mass General Hospital March 2001 - February 2008

Executed daily operations of blood bank.

Daily testing of patient samples, dispense derivatives, blood components, and reference lab.

Quality Control of all reagents in all phases of the laboratory.

Processed & Labeled - Autologus Donors and General donors- ROSYS - Immucor for all donor testing.

Frozen Lab: Deglycerolized and frozen blood (glycerol) of donors, and maintain frozen inventory.

Trained new personnel in blood bank procedures and policies.

Entered data from analysis of medical tests and clinical results into computer.

Successfully completed and passed CAP, AABB, and FDA inspections.

EDUCATION AND TRAINING

MBA: Management

Cambridge College Cambridge, Ma June 2009

Bachelor of Science: Medical Laboratory Science / Sociology

Northeastern University Boston, MA June 1984

ASCP/NCA

Certificate Advanced User Program: Information Technology

Orchard Harvest Software Indiana December 2016

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