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Senior Quality Specialist, Audit

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

About the Job

The Senior Clinical QA Specialist, Audit Support is responsible for scheduling, preparing, and assisting with external and internal audits which best fit the needs of FMI’s Quality Systems and our patient-focused quality culture. The position has strong regulatory knowledge and the ability to deliver results on schedule in a fast-paced and dynamic environment. The Senior Clinical QA Specialist, Audit Support is detail-oriented with excellent organizational skills and able to assess new challenges and prioritize accordingly.

This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Key Responsibilities

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

• Issue audit observations/recommendations.

• Ensure audit observations/recommendations and responses are formally tracked.

• Prepare reports of audit and inspection observations.

• Demonstrate proficiency in the application of the Corrective and Preventative Action (CAPA) System.

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

• Work in a collaborative manner across departments.

• Maintain familiarity with internal laboratory operating and quality assurance/quality control procedures to effectively perform function.

• Support, maintain and continually improve Quality Systems.

• Maintain availability to work outside of a regularly scheduled shift.

• Travel domestically up to 10% of the time.

• Support other QA duties as assigned.


Basic Qualifications

• Bachelor’s degree in a relevant field

• 2+ years in a GMP QA role

Preferred Qualifications

• Previous experience in a GMP QA role in the pharmaceutical, biotechnology, or diagnostic industries

• Previous inspections management and Document Control/Record Management experience

• Exposure to regulatory compliance knowledge including GMP, GCP, CAP/CLIA, ISO15189 and ISO 13485

• Experience working with electronic quality management systems

• Ability to multitask within specified timelines

• Detail oriented with excellent prioritization and organizational skills

• Understanding of HIPAA and importance of privacy of patient data

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

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Internal applicants, please use your FMI email address.

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