QA Coordinator

Organization: 
Sequenom, Inc.
Job Location: 
Morrisville, NC
Salary: 
Competitive salary, bonus, stock options
Job Description: 

Join the clinical laboratory that is dedicated to improving healthcare through revolutionary genetic analysis solutions. The rapidly growing Sequenom Center for Molecular Medicine is on the forefront of ground-breaking clinical diagnostic tests. Sequenom Center for Molecular Medicine, a wholly-owned subsidiary of Sequenom, is a specialty reference laboratory dedicated to the development and commercialization of laboratory-developed genetic testing services for prenatal and eye conditions. Sequenom, headquartered in San Diego, with offices located around the world, provides the opportunity to collaborate with talented and dedicated scientific leaders while developing and expanding your own career. We know our strength and competitive advantage comes from our people so we strive to maintain a motivated team and an environment that supports diversity, encourages creativity, and most importantly, fosters innovation. Our employees are rewarded with excellent compensation and top-notch benefits. Consider joining the Sequenom CMM team, where you can help make an impact in revolutionizing medical technology.

Due to the growth and expansion of our laboratory in the Research Triangle Park area of North Carolina, we are looking to hire a QA Coordinator. This position will support Sequenom Center for Molecular Medicine clinical Laboratory operations for the required laboratory Standard Operating Procedures (SOPs), the Laboratory Information Management System (LIMS), specimen, reagent and personnel records and all required licensing and certification for the laboratory and its staff. The ideal candidate will assist in process improvement and process design to rigorously apply Quality methods to comply with federal, local and company regulatory standards.

Responsibilities:
• Provide support with the clinical Laboratory staff, ensure that Standard Operating Procedures (SOPs) are properly documented, approved, and updated according to requirements
• Ensure that all required CLIA, CAP, state, and other regulatory body licenses, certifications, and notifications are submitted, obtained, and maintained
• Work closely with QA Supervisor to ensure all aspects of the Quality Assurance process are completed within the accepted timeframe and according to division standards
• Maintain appropriate and secure files of the clinical Laboratory documents and SOPs
• Assist with document control database updates, maintain manual documents for approval, promote active QA manual documents, and format QA Manual documents per requirements
• Coordinate ongoing maintenance of technical policies/procedures retained under document control
• Assist with maintaining equipment and calibrations on a timely basis

Requirements: 

• Bachelor’s Degree in a scientific discipline required
• American Society of Clinical Pathology (ASCP) certification or equivalent high desired
• 3-5 years’ experience in the life science industry. Previous experience working in a clinical diagnostics laboratory required
• Familiarity with QC rules and their application within the laboratory, and knowledge of laboratory regulations and licensing requirements a must
• Experience with regulatory or licensure aspects of the life science industry
• Computer proficiency – MS Windows, MS Word, MS Excel, MS PowerPoint and understanding of document control and databases
• Experience with Laboratory Information Systems a plus
• Strong organizational skills to manage timelines, deliverables, resource demands, and conflicts
• Ability to work the following schedule: Monday-Friday, 8:30 a.m. – 5:00 p.m.

EEO/AA M/F/V/D

Contact Information: 

To apply, please visit http://www.sequenom.com/Careers/Jobs