Sr. Quality Assurance Specialist

• Location: Los Angeles, California
• Type: Direct Hire
• Job #38319

Now looking for a Senior Quality Assurance Specialist for a large and rapidly growing CLIA and CAP accredited laboratory!

Position is responsible for managing, enforcing, coordinating and maintaining all functions associated with the company’s Quality Management System. While focusing on the Quality Management System (QMS), the Quality Assurance Specialist will work closely with the Laboratory Medical Directors and Management to provide direction, oversight and input into the management and monitoring of the regulated areas. The Quality Assurance Specialist will be responsible for more than one site, but in addition will need to work with all other sites with regards to processes such as operating procedures, process improvement and occurrence management. The Quality Specialist assumes responsibility for maintaining a constant state of regulatory compliance.

Key Job Elements:

• Ensure and enforce compliance to the company QMS. Included will be the co-hosting and appropriate follow-up to site specific inspections by external regulating agencies (e.g. College of American Pathologists).
• Direct internal audit program for regulated areas as defined by the QMS. Document audit findings, report findings to the Medical Directors and inspect to verify completion of follow-up activities.
• Administer and monitor the Occurrence Management program.
• Enforce key performance indicators for quality as established by the Laboratory Medical Director.
• Ensure compliance of Proficiency Testing programs.
• Review & approve Standard Operating Procedures (SOPs) for compliance to the QMS.
• Assess proper level of training & competency for process changes.
• Manage elements of document control.

Knowledge & Experience:

• Bachelor’s Degree in chemistry, biology, or related discipline.
• 3+ years’ experience in a Clinical/Anatomic Pathology Laboratory setting preferred.
• 3+ years’ Experience with Quality Management/Improvement, including performing audits and demonstrated record enforcing regulatory standards
• Certification as a Clinical/Medical Laboratory Scientist or sub specialty (e.g. ASCP certified Med Tech).
• Demonstrated leadership and management responsibilities within a regulated environment.
• Demonstrated skills in training, validation of clinical assays, written/oral communication, and computer skills are essential.
• Knowledge and ability to enforce CAP, CLIA, and state regulatory requirements such as New York State Department of Health
• Quality related certification(s) such as ASQ Quality Auditor, Quality Engineer, etc.
• Experience or certification with Lean/Six Sigma, TQM, SPC.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!