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CAPA Coordinator

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The CAPA Coordinator assists with the CAPA System at FMI and supports with day to day administration of the CAPA process, documentation, and retention of the quality records. The Coordinator is responsible for expediting and coordinating a multitude of interrelated project activities pertaining to different daily tasks with changing priorities to ensure the successful completion of CAPA work stream. This position interacts with all departments within FMI.

Key Responsibilities

• Responsible for supporting and maintaining the effectiveness and health of the CAPA Quality System.

• Assist with reporting Key Performance Indictors (KPIs).

• Maintain CAPA statuses due to changes in scope; escalate any barriers to CAPA Manager that will affect initiatives.

• Help develop the CAPA process to manage CAPA status, phase due dates, facilitate extensions and any action item follow-up with owners to ensure all activities are performed timely.

• Review and approve CAPA initiations to ensure it meets the criteria of a CAPA.

• Act as the point of contact for issuing CAPA numbers within the current paper-based system.

• Perform periodic trending of CAPAs to identify systemic issues, action plan approvals, action task due dates, and root cause failure modes.

• Manage and maintain CAPA Database for accuracy and consistency.

• Maintain close communication and collaboration with CAPA manager to adjust priorities as needed and ensure that initiatives stay on target.

• May be required to take meeting minutes and participate during CRB (CAPA Review Board) meetings.

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

• Provide CAPA guidance to CAPA Owners/Managers.

• Assist CAPA Manager with general administrative CAPA support.

• Maintain availability to work outside of regularly scheduled shift.

• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor's Degree or equivalent experience in related field

Preferred Qualifications

• Proficient in MS Office (i.e. Excel, Word, Power Point, Visio, Outlook, etc.)

• General understanding of CAPA and 21CFR820

• 1-2 years experience working in a regulated environment; Quality Assurance experience preferred in medical device or pharmaceutical industry

• Experience in an administrative position

• Ability to multi-task and manage shifting priorities

• Demonstrated ability work independently with minimal supervision

• Effective communicator and works well in a team environment

• Motivated, organized, and has attention to detail

• Understanding of HIPAA and the importance of patient data privacy

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

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Internal applicants, please use your FMI email address.

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