Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Quality Assurance Associate

  • Kit Creek Road, Morrisville, North Carolina, United States
  • Full Time

About the Job

The Quality Assurance Associate assists with quality assurance activities to ensure compliance with CLIA, CAP, NYSDOH, and FDA regulations and requirements. The Associate is responsible for record keeping, documentation, and internal auditing support in collaboration with Laboratory Operations and Facilities, which may include the review of clinical batch records and equipment files.

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 root cause, corrective action, and investigations.

• 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.

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

• Other duties as assigned.

Qualifications

Basic Qualifications

• HS Diploma or GED equivalent

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

Preferred Qualifications

• Knowledge or experience in the areas of:

  • GLP, GCP, and GDP disciplines
  • Regulatory compliance including CAP, CLIA, GMP, NYSDOH, FDA, 21 CFR Part 11, and 21 CFR Part 820

• 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

• Strong analytical and problem-solving skills

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

• Understanding of HIPAA and the importance of patient data privacy

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

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Internal applicants, please use your FMI email address.

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Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.