HealthTrackRx · 19 hours ago
Enterprise Quality Support Specialist
Louisville, KY
Full-time
Onsite
Entry, Mid Level
2+ years expHealthTrackRx is a company focused on quality support within healthcare operations. The Enterprise Quality Support Specialist plays a crucial role in maintaining document control systems and ensuring compliance with regulatory standards while supporting Quality Management System initiatives across the organization.
Health CareHealth DiagnosticsHospital
Hiring Manager
Courtney Kriz
Responsibilities
Administer the organization’s document control systems and assist end users with questions and issues, including onboarding and off-boarding personnel in the various software portals
Write, update, issue, and maintain documentation templates, including but not limited to SOPs, Work Instructions, Forms, Technical Files and Specifications
Manage the document control process including the assignment and tracking of document control numbers, management of the document review, revision and approval process, distribution of approved and/or effective documents, maintenance of document archives, and management of appropriate documentation retention)
Collaborate with other departments on the implementation of department specific documentation vaults and provide document control system training to staff, as needed
Coordinate and respond to requests for controlled documents during internal and external audits and inspections
Provide oversight for the distribution, maintenance, and destruction of physical copies of controlled documents at all HealthTrackRx-affiliated facilities
Assist with document retention and destruction as required by applicable laws and regulations
Assists with the creation and implementation of Quality Assurance programs with non-laboratory departments at HealthTrackRx
Facilitate communications between QA Management and non-laboratory departments as they relate to Quality Assurance programs
Performs audits, track metrics, and present findings as they relate to the implementation of Enterprise-wide Quality Assurance programs
Maintain procedural manuals for all areas of the laboratory
Participates in audits and accreditation inspections, at the capacity requested by management
Maintains knowledge of laboratory procedures and policies for document control review and update
Manage the controlled copies and hard copies of documents for the production floor
Performs a variety of support duties to generate documents, ensure accuracy and distribute documents
Obtains documentation and data to assist in the creation of monthly/annual Quality Reports, as well as establish effective systems to monitor accuracy assessments and data quality through Tableau
Provides orientation/training to all new hires as well as current staff, as needed
Participate and communicate departmental changes to senior leadership and C-suite
Accepts responsibilities as assigned by the Quality Director
Acts as a member of the Safety and QA/PI Committee, attends meetings and implement changes, as needed
Reviews and maintains records of maintenance
Participates with the Quality department in overseeing all clinical laboratory departments in a manner conducive to optimal performance and high morale
Qualification
Required
Bachelor's degree in a healthcare related field required
Strong interpersonal and teamwork skills and the ability to build productive working relationships across a diverse spectrum of people
Strong independent worker
Working knowledge of document control principles, and regulatory requirements (e.g., Good Documentation Practices, CLIA/CAP standards, ISO standards, and FDA regulations)
Proficiency in Microsoft Office programs such as Outlook, Excel, Word, PowerPoint, and Teams
Excellent oral and written communication skills
A critical thinker and meticulous attention to detail
Robust organizational with the ability to manage multiple projects simultaneously
Prior experience in document control within clinical laboratory, pharmaceutical, medical device, or related industry
Prior experience administering documentation management systems
Preferred
2 years prior clinical laboratory experience, preferred
Prior experience writing technical documents
Prior FDA document control and 501k experience preferred
Document management certification (i.e., DMCP) strongly preferred
Company
HealthTrackRx
HealthTrackRx provides next-morning infectious disease results, empowering providers with faster answers and better patient outcomes.
201-500 employees
H1B Sponsorship
HealthTrackRx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2015-01-01Private Equity
Leadership Team
Martin Price
Executive Chairman & CEO
Harriss Currie
Executive Vice President, Chief Financial Officer
Recent News
2025-12-11
BioWorld Financial Watch
2025-09-24
Company data provided by crunchbase