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Clinical QA I

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

Job Summary

The Clinical QA I supports hosting external audits and is responsible for planning and facilitating audit activities. This position works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and to support a diverse array of projects and initiatives. The Clinical QA I contributes to QA activities across multiple quality system requirements (CLIA/CAP, GCP, ISO and FDA regulated environments).

Key Responsibilities

• Support hosting external audits performed by regulatory/inspections agencies, surveys and clients, such as pharmaceutical companies or referral laboratories.

• Facilitate audit/inspection readiness training and activities.

• Track and monitor audit commitment to ensure timely response.

• Support the issuance audit observations/recommendations.

• Support the preparation of audit reports and inspection observations.

• Support the compilation of audit findings and responses as metrics for management purposes.

• Assist in the internal GCP activities, such as internal audits.

• Travel domestically up to 10% of the time.

• Support other QA duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in a science or engineering discipline and 3+ years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in clinical trials; OR,

• Master’s Degree in a science or engineering discipline

Preferred Qualifications

• Experience or familiarity with Companion Diagnostics

• Scientific background in molecular biology and/or NGS

• Demonstrated ability to maintain accurate audit records

• Knowledge of Microsoft Office applications (e.g. Word, Excel, Powerpoint)

• Knowledge of root cause analysis and corrective and preventative action

• Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements

• Ability to effectively communicate verbally and in writing within the team and with other functional teams

• Ability to cooperate and collaborate effectively with a team

• Highly detail oriented

• Excellent time management skills and ability to deliver requested tasks on time

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

 

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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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)

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