CAPA Facilitator Associate

Hologic•Newark, DE

9h•$78,000 - $122,100

About The Position

We currently have two opening for a CAPA Facilitator Associate. As a CAPA Facilitator Associate, you will support a broad range of quality system and quality assurance activities. You will use data, quality tools, and cross-functional collaboration to assess issues, document outcomes, support investigations, and contribute to continuous improvement across the division. This is a fully qualified, career-level position suited to an experienced professional who can work independently on day-to-day responsibilities, exercise sound judgment, and resolve a wide range of quality-related issues in a creative and practical way.

Requirements

Experience working within Quality Assurance, Quality Systems, or a related regulated environment.
Working knowledge of Quality Management Systems, QMS.
Experience supporting CAPA processes, root cause analysis, effectiveness checks, and quality investigations.
Understanding of audit preparation and support activities, including internal audits, external audits, and/or regulatory inspections.
Ability to analyze data and support the development of quality metrics and KPIs.
Experience creating, maintaining, or improving procedures, processes, training materials, or quality documentation.
Strong communication and collaboration skills, with the ability to work across multiple functions and levels of the organization.
Good judgment in selecting appropriate methods, tools, and techniques to resolve quality issues.
Ability to manage diverse tasks with minimal day-to-day supervision.

Nice To Haves

Experience in medical device, pharmaceutical, life sciences, manufacturing, or another regulated industry would be advantageous.

Responsibilities

Support and model quality values, quality system requirements, and best practices across the division.
Collaborate effectively with junior team members, peers, senior stakeholders, and cross-functional teams across the organization.
Coordinate assigned quality activities and provide support to the Quality Assurance department as directed by the Quality Assurance Manager.
Facilitate key quality assurance processes including: Corrective and Preventive Action, CAPA, program activities; Process nonconformance activities; Divisional Management Review administration.
Provide guidance and expertise on root cause evaluation and monitor CAPA effectiveness after closure.
Perform daily reviews of the CAPA system to identify escalations and coordinate with departments to ensure appropriate resourcing.
Own, maintain, and improve the divisional CAPA toolbox, including training materials, reference documents, and supporting resources.
Prepare and manage documentation and follow-up actions from site CAPA Review Board meetings.
Serve as a divisional point of contact for the CAPA process and provide input into global process improvements and training content.
Participate in internal and external quality audits, including supporting front-room and/or back-room audit workstreams.
Support audit and inspection preparation by communicating with functional areas and collecting relevant data to improve audit efficiency.
Administer the collection and organization of divisional Management Review materials.
Modify, maintain, and create procedures and processes as required.
Assist with data analysis and the development of key performance indicators, KPIs, for various functions.
Review open site Quality Plans, QPLs, and provide recommendations for updates.
Support FDA inspections and other regulatory audit activities, as applicable.