COMPLIANCE OFFICER (OKLAHOMA CITY, OK)

Oklahoma Blood Institute•Oklahoma City, OK

3d•Onsite

About The Position

This position manages the external inspection process of the firm's operations, including audit preparation, coordination and hosting of the audit, and submission and implementation of corrective actions, provides oversight of the internal audit program, completes client and vendor qualification questionnaires, supervises the Research and Development Quality Specialist, and manages vendor recalls. This position must travel on short notice to host unannounced external audits at any OBI location.

Requirements

Bachelor of Science in clinical laboratory sciences or related field.
Minimum of five years management experience and five years of quality assurance experience.
Demonstrated experience providing leadership and direction in a manner that cultivates respect and influences behavior.
Ability to prioritize and manage multiple projects.
Strong critical thinking skills and independent judgement.
Strong computer skills.
Strong written and verbal communication.
Ability to travel on short notice to be present for external audits at any OBI location.

Nice To Haves

An advanced degree is strongly preferred.

Responsibilities

Perform impact analysis for all organizational changes to identify the impact changes can have on the firm's compliance with local, state, and federal regulations as well as other OBI policies and procedures.
Provide guidance to the organization on federal regulations, CLIA requirements, and AABB and FACT standards.
Direct and host all external audits on the firm's behalf.
Oversee the internal audit program
Supervise the Research and Development Quality Specialist
Notify applicable agencies of proficiency testing (PT) failures.
Assist appropriate areas in the development of corrective action plans for external audits and PT failures.
Ensure corrective actions are submitted to the external auditor or accrediting agency for PT failures and all corrective actions are completed and found to be effective.
Ensure that all pre-audit requirements for accrediting and regulatory agencies occur as required This includes but is not limited to completing pre-audit questionnaires and assembling reports documents and files for the audit.
Coordinate completion and submission of client/vendor questionnaires.
Provide compliance related counsel (i.e. external agency reporting) to the VP of Quality Management.
Serve as the HIPAA Privacy Officer for the firm.
Identify quality and process projects that can be improved using DMAIC principles and six sigma tools.