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Quality Assurance Project Manager

Location:
Shreveport, LA
Posted:
July 28, 2023

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Resume:

Kristen L. Soelter

**** ****** ***** ****., *********, LA, 71033

224-***-****

adykp9@r.postjobfree.com

Analytically-driven director with 15+ years of experience in strategic planning and leading multiple departments to exceed service expectations. Employs statistical data to track and trend key performance indicators for process improvements, areas of risk, root cause analysis, solution implementations, and improved profitability.

CORE COMPETENCIES

LEADERSHIP & MANAGEMENT:

Strategic Planning, Team Building/Mentoring, Process Improvement, Regulatory Compliance, Performance Management, Operational Excellence

FINANCE:

Capital and Operational Budget Planning, Contract Review, Resource Allocation, Root Cause Analysis

WORK EXPERIENCE

LIFESHARE BLOOD CENTER - Shreveport, LA 09/2020-05/2023

Regional Director – Pelican Plasma

Provided strategic leadership and oversight to ensure the successful opening of a new independent plasma center: contract review; capital and operational budget development and adherence; ensured requirements from all regulatory agencies and stake holders were addressed; and monitored data and performance to identify opportunities for improvement. Strengthened ties to the community with outreach and participation in local chamber of commerce.

Lead site through multiple successful inspections/audits resulting in licensure from all regulatory agencies thereby permitting product shipment. Average monthly sales ~$350,000.

Responsible for designing promotions and social media postings resulting in increasing collections by more than 1500% within the first two years of operation.

LIFESHARE BLOOD CENTER - Shreveport, LA 06/2016-09/2020

Senior Director of Operational Support

Formed and oversaw the record review, data entry, technical writing, technical support, and training departments. Developed processes and procedures to streamline operational functions. Coordinated implementation and updates of new equipment, software, procedures, and products across multiple sites. Collaborated with and monitored sites for areas of improvement using key performance indicators. Ensured validation documentation was complete and accurate for submission for licensure. Reviewed, updated, and adhered to the approved operational budgets.

Standardized quality review of operational documentation resulting in accurate reporting to identify areas of improvement and track effectiveness of solution; decreased documentation errors by 300%.

Increased platelet exports by 1000% with effective monitoring, usage projecting and communication within the team and other stakeholders.

INSTITUTE FOR TRANSFUSION MEDICINE – Rosemont, IL 01/2014-05/2016

Regional Manager

Supervised 160 phlebotomists with 55 direct reports. Coached and monitored team for compliance and ensured established operational thresholds (KPI) were attained. Reviewed and provided feedback on controlled documents and validations prior to implementation/execution. Developed and adhered to operational and capital budgets for department. Monitored and resolved customer complaints. Partnered with other operational teams for drive success, customer satisfaction and inventory demands.

Created educational program and provided training on delivering an “Exceptional Donation Experience” which decreased the number of donor complaints, increased donor compliments and increased team member satisfaction within their role.

INSTITUTE FOR TRANSFUSION MEDICINE – Rosemont, IL 01/2012-01/2014

Quality Control Document Specialist

Reviewed and investigated non-conformances. Identified trends and acted as the lead on root cause analysis projects. Presented alternatives to current practices. Prepared regular quality indicator reports for senior management. Led quality management indicator meetings and report outs. Purposed new quality indicators and analyzed thresholds of current indicators. Worked with medical and other support teams to ensure compliance to all regulatory bodies, i.e., FDA, AABB.

Developed reporting tool to ensure staff competencies were maintained in accordance with regulatory agencies requirements.

INSTITUTE FOR TRANSFUSION MEDICINE – Rosemont, IL 09/2005-01/2012

Application Administrator

Troubleshot system issues, provided assistance and training to users, wrote standard operating procedures and policies, performed validations for implementations/upgrades. Led implementation teams for the configuration of operations and quality assurance training modules. Applications: MasterCONTROL and Title 21.

Automated the document approval cycle decreasing the length of time from collaboration to implementation; as well as automated the training every employee which resulted in improved oversight of training compliance.

EDUCATION & CERTIFICATIONS

LOUSIANA STATE UNIVERISTY SHREVEPORT - Shreveport, LA 01/2021-12/2024

MBA – Healthcare Administration

DEPAUL UNIVERSITY – Chicago, IL 08/2000-06/2004

BS – Biology

LOUISIANA STATE BOARD OF MEDICAL EXAMINERS – Baton Rouge, LA 03/2023-04/2023

CLS – Laboratory Assistant

ADDITIONAL EXPERIENCE & PROFESSIONAL ACCOMPLISHMENTS

INSTITUTE FOR TRANSFUSION MEDICINE – Rosemont, IL

Quality Assurance Project Manager

INSTITUTE FOR TRANSFUSION MEDICINE – Rosemont, IL

Corporate Safety Officer

INSTITUTE FOR TRANSFUSION MEDICINE – Rosemont, IL

Testing Coordinator – West Nile Virus

www.linkedin.com/in/soelter-kristen-55220131



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