1. Monitor continuously policies and procedures in MediaLab to ensure the clinical laboratory meets respective standards and regulations; support regulatory registrations, inspections, and reporting.

2. Review and document nonconforming events, conduct investigations, perform root cause analysis, and develop corrective and preventive actions.

3. Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback; coordinate processes, reports, and documentation for escalations arising from feedback.

4. Work with validation lead and assist with laboratory validations to compile data, review data and create summarization reports.

5. Support Laboratory Manager and Laboratory Supervisors as part of a team with directed projects to assist in any way deemed needed.

6. Apply exceptional written and verbal communication skills.

7. Strong attention to detail, organization, and record-keeping skills.

8. Strong leadership and decision-making skills; ability to communicate ideas, opinions, and counter arguments in a proactive and professional manner.

9. Support and comply with the company’s Quality Management System policies and procedures.

Job Requirements

1. Bachelor’s degree in a Science or field as outlined in essential duties.

2. 4 years of experience in clinical laboratory field. Bonus would be having quality management system experience.

3. Demonstrated understanding and professional working knowledge of CLIA, COLA, CAP, HIPAA, OSHA, or other regulatory body.

4. Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

5. Must demonstrate superior team focus; ability to communicate openly and transparently with peers, supervisors and other departments; ability to accelerate and embrace change throughout CSL.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)