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Associate, Quality Assurance

Full Time | Morrisville | North Carolina | United States

About the Job

The Quality Assurance Associate assists with quality assurance activities to ensure compliance with CLIA, CAP and FDA regulations and requirements. The Associate is responsible for record keeping, documentation and internal auditing in collaboration with laboratory operations and facilities which may include the review of clinical batch records and equipment files. Additionally, this position supports training on site-specific quality assurance principles for new staff members.

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

Key Responsibilities

• Maintain, update and version policies and protocols.

• Ensure that record keeping under FDA/GLP requirements are attributable, legible, contemporaneous, original and above all, accurate.

• Support Laboratory Operations and Quality in the review of quality documents, including but not limited to clinical and FDA batch records.

• Support Facilities to ensure that equipment standards are tested, calibrated and standardized before patient testing, and that activities are documented and approved.

• Support and assist validation documentation activities as required.

• Manage employee training files as needed.

• Provide departmental training as needed as part of Site New Employee Onboarding Training.

• Assist with record management and maintenance duties such as scanning, copying, and organization of electronic documents.

• Assist in all aspects of the full operation, implementation, and maintenance of the onsite document control room including controlled issuance, retrieval, and archiving of CLIA, CAP, and FDA regulated documents to support site operations.

• Support FDA and other regulatory agency inspections in backroom support/document retrieval.

• Work with management in compiling required metrics and data for monthly Quality meetings and/or management review activities.

• Travel for quality assurance activities up to 10% as needed.

• Provide support and contribute to other Quality Assurance activities as needed.


Basic Qualifications

• High School Diploma or General Education Degree

• 2+ year of work experience within a quality assurance, compliance, document control or similar function

• Experience working within a regulated environment

Preferred Qualifications

• Knowledge or experience in the areas of:

·   GLP, GCP, and GDP disciplines

·   regulatory compliance including GMP, FDA, and 21 CFR Part 11

• Prior experience:

·   working with Document Control or Record Management

·   working with electronic document management and quality management systems

·   within the medical device/diagnostics industry

• Detail oriented with excellent prioritization and organizational skills

• Superior analytical and problem solving skills

• Demonstrated ability to deliver results on schedule in a fast-paced, dynamic environment

• Ability to travel up to 10%

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to reflect FMI’s values: Passion, Patients, Innovation, and Collaboration

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Internal applicants, please use your FMI email address.

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