Quality Management Specialist

Decipher Biosciences, a subsidiary of Veracyte, Inc., is a dynamic entrepreneurial startup molecular diagnostics company focused on cancer genomics. Whether on the phone with patients, or in the cloud with big data, our innovators are working hard to give back to the patient what cancer takes away: information for life.

SUMMARY:

Quality Management Specialist will work directly with stakeholders from all departments of the company to maintain established Quality Management Systems and processes ensuring compliance with the regulatory agencies. This role will rely heavily on effective communication, creative solutions, thorough documentation and timely delivery.

ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.

• Administer the organization’s electronic document control management system.
• Support validation activities.
• Participate in internal audits to ensure processes comply with established procedures; support audits by the external parties.
• Interacts with Government and Regulatory Agencies as appropriate on behalf of the Laboratory.
• Maintain State, Federal and other certifications and licenses as deemed necessary for the operations of the Clinical Laboratory.
• Train staff members in the Quality System as necessary to ensure compliance to Decipher Biosciences Inc. and Regulatory standards.
• Maintains and updates safety programs for the organization and assure compliance to OHSA standards.
• Leads and ensures annual safety training for all employees.
• Performs other duties as assigned.

REQUIREMENTS: QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

• Bachelor’s degree in a Sciences discipline or equivalent with 2+ years relevant experience or associate degree with 3+ years’ experience.
• Experience in a clinical testing laboratory environment performing Quality Assurance functions such as SOP and protocol writing or review, record and data review, investigations into deviations and out of specification results, training and auditing.
• Be familiar with CLIA, CAP and New York requirements.
• Detail oriented and strong written and verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member. 
• Demonstrated ability to follow detailed directions in a laboratory environment. 
• Must be familiar with Microsoft Office applications.

PHYSICAL REQUIREMENTS

• Repetitive movement of hands, arms, legs and fingers (typing and/or writing)
• Sitting, with occasional walking, standing, stooping and moving about
• Exposure to general office environment conditions
• Talking and hearing
• Occasionally required to lift up to 25 pounds

Equal Opportunity Employer: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.