Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Michael Aussey

Virginia Beach

Summary

To obtain a position in a company that supplies quality products to a global market.

Motivated leader with strong organizational and prioritization abilities in Quality Assurance, Quality Systems, Production, and Business acuity.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Director, QS Documents and Analytics

LifeNet Health
Virginia Beach
08.2022 - 09.2025
  • Provides oversight to Document Control, Post-Production, and QS Analytics teams by supervising, guiding, and directing employees to be effective team members.
  • Ensures that team members are equipped with the right skills, tools, and talents necessary for executing their duties.
  • Uses established people processes (performance, development, succession, and career) to ensure their team's level of performance and capabilities meets current and future standards.
  • Identifies and performs statistical analyses for complex data sets and validates findings from all QS teams.
  • This includes analysis on all data points associated with donor post-production review/release, document control, and graft implant record management.
  • Utilizes operational experience to translate data into insight. Communicates, presents findings, and translates data/analytics into informative recommendations to consider.
  • Leads efforts to assess strategic forward-thinking decisions based on analytics, ad-hoc queries, and BI/data warehouse system information.
  • Directs all operational aspects of LifeNet Health's Document Control system, ensuring related activities, applications, storage methods and retention periods remain in compliance with applicable regulations, standards, and guidelines.
  • Oversees the development, implementation, and maintenance of new processes designed to enhance the effectiveness and efficiency of the graft implant records program.
  • Ensures systems in place for reviewing production documentation and corresponding laboratory results are efficient and remain effective in ensuring allografts bio-implants released to distributable inventory are safe for implantation.
  • Ensures project/department milestones and goals are met and adhering to approved budgets.
  • Provides QS representation on standing cross-functional teams, as well as project teams, such as: Nonconforming Material Review Board, 8D teams and other relevant groups.
  • Maintained working knowledge of 21 CFR 1271, 21 CFR 820, ISO 13485, and AATB Standards.
  • Led strategic planning initiatives to align organizational goals with market trends.

Quality Systems Manager

LifeNet Health
Virginia Beach
10.2019 - 08.2022
  • Manages, oversees, and coaches Quality Systems Post-Production personnel in the commission of duties related to: compiling and reviewing production records, releasing grafts to distribution, reviewing product sterilization records, scheduling daily work flow, maintaining and analyzing metrics, implementing and removing quality holds, and reviewing/resolving open nonconformance and complaints.
  • Ensures department milestones and goals are met and adhering to approved production budgets.
  • Manages escalated issues arising from tissue banking operations and ensures coordination with key stakeholders from other departments for sustainable corrective actions.
  • Ensures implementation of LEAN principles to strengthen, improve and/or create process controls related to Post-Production processes.
  • Provides QS Post-Production representation on cross functional teams to support efforts in product development/launch, problem resolution, and continuous improvement efforts.
  • Maintains and constructs new reports based on value added Key Performance Indicator data from multiple databases.
  • Maintained working knowledge of 21 CFR 1271, 21 CFR 820, ISO 13485, and AATB Standards.
  • Completed competency in Global Certified ISO 13485: 2016 Auditor Training.

Quality Assurance Manager

LifeNet Health
Virginia Beach
02.2012 - 10.2019
  • Monitors status of donor records using manual and computerized tracking systems. Compiles data and prepares statistical reports to track department activity to ensure that all appropriate efforts are made to meet corporate workflow metrics.
  • Oversees the workflow, prioritizes tasks or daily activities, and works closely with the supervisors to ensure effective operations of the department utilizing lean principles.
  • Directs oversight responsibility for tissue quality assurance activities, including the assessment of donor suitability, in-process inspections, compilation and sharing of information with internal departments and external partners/agencies.
  • Ensures that donor tissues/grafts meet applicable criteria set forth by LNH SOP, FDA regulations & guidance, AATB standards, and State/Federal regulations prior to release.
  • Assists in review, investigation, and resolution of departmental Non-Conformance reports. Investigates Complaint reports, in conjunction with Quality Systems and the Quality Assurance Vice President.
  • Coordinates the development and maintenance of effective Standard Operating Procedures for Quality Assurance and recommends changes as needed.
  • Collaborates with the Vice President/QA Director in the preparation for justification of new resources within the Quality Assurance Department.
  • Assists Training Coordinator with the review of training materials and trainee work in order to ensure trainee has a well-rounded understanding of QA processes and procedures.
  • Conducts review of unsuitable donors and determines payment of invoices to recovery partners based on LifeNet Health procedures, as well as, approving invoices of payment to external agencies for third party records.
  • Performs evaluations of employee work performance and provides timely feedback monthly, mid-year, and end of year in order to determine employee's ability to meet corporate and personal developmental goals.
  • Reviews recovery partner's revisions to paperwork for compliance with regulatory and LifeNet Health standards and provides feedback/recommendations to recovery partner's documentation practices.
  • Maintains and constructs new reports based on value added Key Performance Indicator data from multiple databases.

Center Director

Octapharma Plasma
Portsmouth
01.2008 - 02.2012
  • Supervised donor screening, plasma collection and plasma processing in a highly regulated biotech industry.
  • Maintained production/manufacturing records in accordance with all regulatory requirements.
  • Monitored and evaluated operations, to include budget and provided feedback to the Regional Manager on efficiency of operations.
  • Retained meticulous documentation pertaining to Federal State regulations, FDA approved Standard Operation Procedure manual, OSHA, CLIA, and cGMP.
  • Conducted formal/informal interviews, completed employee annual appraisals, and resolved complaints from employees and donors.
  • Trained new employees, re-certified current employees, and performed routine based observations in all aspects of plasma production.
  • Facilitated public relations by marketing the Hampton Roads Octapharma centers through newspaper print, television commercials, and flyers.
  • Performed as a trained phlebotomist, donor screener, and plasma processor as back up to all employees during this time frame.

Quality Assurance Supervisor

Octapharma Plasma
Portsmouth
06.2008 - 12.2008
  • Evaluated and ensured staff compliance with Standard Operating Procedures, SOP revisions, and Non Conformance action plans.
  • Administered deviation investigations including CAPA response to trends in errors and accidents, external and internal audit findings.
  • Monitored and evaluated adequacy of CAPA, completeness of reports, and assisted in root cause analysis.
  • Performed routine training with staff to ensure full comprehension of applications of SOPS according to employees' job function.
  • Reviewed calibration and validation records to ensure equipment operations met standards and were in compliance with all routine preventative maintenance.

R & D/Lead Musculoskeletal Technician

LifeNet Health
Virginia Beach
11.2004 - 06.2008
  • Processed musculoskeletal cadaveric tissue in a class 100 clean room while maintaining all aspects of cGTPs and cGMPs.
  • Trained new employees on proper clean procedure including but not limited to, surgical scrub, and various processing Standard Operating Procedures.
  • Developed processing protocols and training modules for Research and Development and Tissue Operations.
  • Educated employees on specialty grafts, such as, Vertigraft 1 and 2, TLIF, and meniscus soft tissue grafts.
  • Maintained databases for graft production and estimated graft yields.

Education

Bachelor's Degree - Liberal Arts in English Literature

Longwood University

Skills

  • Proficient in the following applications and databases: Donor Record Library (SharePoint Libraries)
  • Customized secure document management System SAP TDTS (Custom Database, Donor Management System) Sharepoint applications
  • AATB Certified Tissue Banking Specialists
  • FDA Regulations
  • CGMP
  • Internal Audits
  • Quality Assurance
  • Lean Manufacturing
  • Quality Audits
  • Root Cause Analysis
  • Quality Systems
  • ERP Systems

Certification

  • AATB (American Association of Tissue Banking), 09/01/19
  • ISO 13485: 2016 Auditor Training Certification (AQS), 09/01/19
  • Exemplar Global Certified ISO 13485: 2016 Auditor Training, 09/01/19

Timeline

Director, QS Documents and Analytics

LifeNet Health
08.2022 - 09.2025

Quality Systems Manager

LifeNet Health
10.2019 - 08.2022

Quality Assurance Manager

LifeNet Health
02.2012 - 10.2019

Quality Assurance Supervisor

Octapharma Plasma
06.2008 - 12.2008

Center Director

Octapharma Plasma
01.2008 - 02.2012

R & D/Lead Musculoskeletal Technician

LifeNet Health
11.2004 - 06.2008

Bachelor's Degree - Liberal Arts in English Literature

Longwood University
Michael Aussey