Summary

Foundation Medicine is seeking a Quality Assurance Specialist. This position will assist with QA activities at Foundation Medicine to ensure compliance with CLIA, CAP and FDA regulations and requirements.

Primary Responsibilities and Essential Duties

• Responsible for maintaining, updating and versioning of policies and protocols.
• Ensure that record keeping under FDA/GLP requirements are attributable, legible, contemporaneous, original and above all, accurate.
• Ensure that equipment standards under FDA/GLP standards are properly maintained, cleaned and inspected on a routine basis per SOPs. Manage IQ/OQ activities of new equipment, and oversee annual PM activities. Document all appropriately
• Works with the Clinical Laboratory Director and QA Director to review all Quality documents.
• Responsible for ensuring that equipment standards are tested, calibrated and standardized before patient testing, and that all must be documented and approved.
• Demonstrate strong  proficiency in the application of the Corrective And Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources
• Help manage Lot to Lot validations of new reagents
• Manage employee training files
• Responsible for maintaining and filing both paper and electronic pdf records.
• Assist in development and management of FMI quality management system.

Required Skills and Experience

• Must have strong regulatory compliance knowledge including GLP and GCP
• Able to assist with external audits of vendors and subcontractors
• Must be detail oriented with excellent prioritization and organizational skills
• Superior analytical and problem solving skills
• Must be able to deliver results on schedule in a fast-paced, dynamic environment

Desired Skills and Experience

• Experience in the diagnostics industry strongly desired

Education or Experience

Bachelor’s degree with at least 5 years of experience in the pharmaceutical, biotechnology, medical device, or diagnostic industries, at least 2 of which should include direct QA experience.