This is an exciting time to join our dynamic organization. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets, including pharmaceuticals, diagnostics, and biologics. OPKO's diagnostics business includes BioReference Laboratories, the nation's third-largest and fastest growing clinical laboratory over the last 35 years, which provides diagnostic testing to physician offices, hospitals, and clinics, among others, and GeneDx, a rapidly growing genetics and genomics laboratory that applies cutting edge technologies to make efficient clinical diagnostic testing and interpretation available for individuals with rare and common genetic conditions. Come join our team and become part of something big, by making our patients and customers the highest priority.

GeneDx is seeking a Quality Systems - Document Control & Retention Specialist

GeneDx is a rapidly growing CAP and CLIA certified diagnostic genetic testing laboratory for molecular genetics. Our historic mission has been to make clinical diagnostic testing available for people with genetic conditions and their families. We apply cutting edge technologies that provide a wide array of molecular genetic diagnostic tests, including whole exome sequencing and next-generation sequencing panels. We specialize in genetic testing for rare hereditary disorders, but also test for common disorders. To learn more about GeneDx, please visit our website at www.genedx.com.

Responsibilities include:

• Implements Quality Systems programs that are consistent with company policies and regulatory standards


• Implements and manages the record retention program.
  
  


• Manages the document control system - ensuring timely review and document completeness
  
  


• Maintains tools for monitoring compliance training, corrective actions, audits, and document control


• Assists with audits and record keeping


• Assists with validation package review


• Performs additional related duties as assigned.

• B.S. degree in related field


• 1-3 years of experience in a regulated life science laboratory


• Early to mid-level career professional


• Proven ability in maintaining professional accuracy and deadlines


• Experience New York State-licensed laboratory preferred


• CAP Inspector certification preferred

• Paid Time Off (PTO)


• Health, dental, vision, life insurance, LT/ST disability plans


• Flexible Spending Account (FSA)


• Health Savings Account (HSA)


• 401K retirement savings plan with company match


• Employee Discounts


• Regular performance appraisals


• Promotions from within


• Business casual dress code