Quality and Compliance Coordinator

The quality and compliance coordinator will work with the quality team to ensure quality and compliance throughout the company, ensuring adherence to various standards, regulations and laws. This team member will have a specific focus on ensuring specimen collector compliance, but will also work with the quality team to ensure quality and compliance company wide.

Duties:

• Review compliance of laboratory care specialists (specimen collectors) across all collection locations
• Develop regular audit schedule for laboratory care specialists across all collection locations
• Coordinate and monitor the delivery of quality and compliance training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements.
• Collaborates with leaders to identify, coordinate and deliver retraining for the purpose of correcting or improving operational, compliance or quality issues.
• Develop and deliver training sessions related to quality, safety, and compliance
• Ensure thoroughness, accuracy and timeliness of documentation. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
• Maintain and review personnel training documents to ensure documents comply with SOP’s, CLIA/CAP and other applicable requirements.
• Maintain the document control system to comply with company and regulatory standards.
• Conduct periodic process assessments to ensure compliance with written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.
• Identifying and communicating non-conformities.
• Promote policies and procedures. Ensure safety and compliance training and safety and compliance practices are implemented at collection locations
• Conducts and may lead internal audits to monitor collector compliance with procedures and policies, OSHA, FDA, and other regulations, as applicable, and develop responses for deficiencies.
• Responsible for initiating, investigating and closing reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.
• Maintain a clean, efficient work environment.
• Follow all Standard Operating Procedures (SOPs), company policies and procedures.
• Comply with all local, state and federal regulations and laws.
• Maintain confidentiality
• Assist in special projects, as assigned

• Bachelor's degree
• Proven experience in quality and compliance (clinical lab industry) is preferred
• Strong understanding of applicable regulations (OSHA, CLIA, EKRA, STARK, etc) and/or strong understanding of other regulations with the ability to learn applicable regulations
• Excellent written and verbal communication skills
• Strong organizational skills and attention to detail for maintaining training records and compliance reports
• Strong communication skills, with the ability to effectively explain complex safety regulations and procedures to a diverse workforce
• Ability to adhere to regulations when conducting audits and deploying corrective actions
• Ability to travel 65-75% of time