Overview

This position will report into the (Associate) Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients.

Opening Investigation and closing out with CAPA.

Essential Functions and Responsibilities

  • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes.
  • Develops and communicates investigation strategy to key stakeholders.
  • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log
  • Reviews and approves investigations and CAPAs;
  • Conducts weekly status update meetings with cross functional departments and other stakeholders.
  • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis.
  • Prepares and issues change control as necessary.
  • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures.
  • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
  • Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
  • Performs supplemental investigations and/or participates in project teams or assignment as necessary.
  • Support in agency, internal and/or client audits.

Qualifications

  • B.S in biological sciences or other relevant field of study.
  • Minimum 7 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
  • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
  • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
  • Familiar with FDA, ISO, and other regulatory agency guidelines.
  • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
  • Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
  • Experience in both clinical and commercial manufacturing is preferred.
  • Experience in supporting health authority inspections and/or client audits preferred.