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Specialist, Right to Operate

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

About the Job

The Right to Operate Specialist is responsible for supporting the Clinical Laboratory in adhering to state, local and federal regulations as well as internal policies and procedures. The position applies regulatory knowledge in fulfilling their job responsibilities and collaborates cross functionally to support client requests and follow up during onsite audits.

Key Responsibilities

• Maintain lab operation staff training/personnel files.

• Support Quality Assurance in the procurement of documentation and fulfillment of requests for external audits.

• Follow company policies and applicable procedures.

• Execute work with adherence to GCP requirements and applicable regulations, including, but not limited to, CLIA, CAP, MA state, NY state.

• Act as a laboratory operations liaison to internal customers.

• Review competency assessment forms and ensure competency assessments are completed on time; maintain, monitor and report on competency assessment KPI and metrics.

• Assist with Non-Conformance Report generation, review and trending.

• Partner with the Laboratory Operations Management team in creation and review of Quality documents.

• Respond to audit findings and coordinate the completion of response plans.

• Support the continuous improvement of laboratory processes.

• Support the Quality Assurance Internal Audit Program.

• Support laboratory operations CAPA program.

• Support external and internal proficiency programs including report writing.

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

• Travel domestically up to 10% of the time.

• Other projects as periodically assigned.

Qualifications

Basic Qualifications

• Bachelor’s Degree in Biology, Chemistry, or other Life Science field

• 4+ years of experience in the pharmaceutical, biotechnology, medical device or diagnostic industries

• 3+ years of experience with GMP, GLP or GCP processes

Preferred Qualifications

• Prior experience with supplier/vendor management

• Experience with internal/external audit

• Experience with process validation

• Able to work well under pressure while maintaining a professional demeanor

• Able to prioritize and thoroughly follow up on assigned tasks

• Able to handle multiple tasks at once and work in a fast-paced environment

• Able to adapt to changing procedures, policies and work environment

• Detail-oriented, organized and able to shift priorities based upon business needs

• Excellent communication skills to effectively collaborate cross functionally

• Understanding of HIPAA and the importance of patient data privacy

• Demonstrated integrity and a commitment to values held at FMI: patients, innovation, collaboration, and passion

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