Enterprise Quality Support Specialist

Enterprise Quality Support Specialist

The Enterprise Quality Support Specialist will primarily service in the Quality Department and provide support for Enterprise-level projects that are related to departmental document control functions. Enterprise-level Quality support will involve maintenance and administration of document control systems to ensure that processes align with internal procedures and applicable regulatory requirements. Administration of this system includes the development and implementation of documentation procedures including organization, storing, updating, archiving, and distributing controlled documents throughout HealthTrackRx. The Specialist will service all departments through HealthTrackRx as it relates to administration of documentation systems and other job functions as they relate to the establishment and maintenance of an Enterprise-wide Quality Assurance Program.

Responsibilities/Duties:

• 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 nonlaboratory 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.

Quality Department-Specific Job Functions:

• 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 implements 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.

Qualifications:

• Education – Associate degree in a healthcare related field required.
• Bachelor's degree strongly preferred.
• Competencies/Skills – 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.

Experience – Prior experience in document control within clinical laboratory, pharmaceutical, medical device, or related industry. Prior experience administering Media Lab, Master Control, or other documentation management systems. 2 years prior clinical laboratory experience, preferred. Prior experience drafting technical documents. Prior FDA document control and 501k experience preferred.