This position is responsible for supporting quality assurance objectives for an advanced pathology laboratory focused on developing and providing quantitative tissue biomarker assay services for the pharmaceutical industry. Under the direction of the Director of Compliance and the business Chief Medical Officer, this new position’s primary role will be to establish, maintain, and monitor CLIA/CAP compliance of Pathology Laboratory.
This position will assist in generating a quality management system to support the CLIA/CAP functionality of the Laboratory, as well as maintain and insure compliance to regulations, laws and company policies.
All work performed in this role will follow local, federal and state regulations including CAP and CLIA.
Essential Duties include but are not limited to:
• Assist in licensure application and laboratory setup up.
• Plan and direct resources and activities of the quality and compliance functions.
• Serve as the site management quality representative
• Create, implement and maintain key quality systems, including quality protocol investigation reports (CAPA, etc.), audit reports, protocols, regulatory submissions
• Conducts training of personnel on quality standards and procedures.
• Schedule, prepare and conduct internal audits against approved procedures and statutory/regulatory requirements.
• Track implementation of corrective actions related to audit findings, including verification of effectiveness.
• Supports regulatory inspections activities (as applicable)
• Administer the CLIA CAPA Program and appropriately escalate any compliance risks to management.
• Review of documentation/records for accuracy, completeness and to ensure good documentation practices are followed
• Advise staff to help meet established schedules or resolve technical or operational problems
• Support Quality functions at other U. S. sites, as needed
• Bachelor s Degree in Physical, Biological Sciences, or technical/scientific field.
• 5-8 years of experience as a Quality Professional in the biotechnology or pharmaceutical industry.
• 3+ years direct experience in management within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
• Knowledge of Histopathology laboratory methods.
• Experience with CAPA and Risk Management processes.
• Knowledge and experience of Quality Systems and regulatory requirements for CAP, CLIA, NYS and other applicable regulations and laws (OSHA, HIPAA).
• Experience with registrations, accreditations or certifications preferred.
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!