QA Compliance Auditor

Worcester, MA, US
Dec 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
AbbVie Bioresearch Center in Worcester, MA is seeking a QA Compliance Auditor to join their team. This QA Compliance Auditor will be responsible for implementing and maintaining a functional internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

Key Responsibilities:

  • Responsible for Regulatory Compliance at the plant level which includes planning and conducting internal compliance audits of all operations within the facility.
  • Serve as plant administrator for all company and regulatory agency (i.e. DEA, FDA) inspections.
  • Convey all violations to appropriate plant management/supervisory personnel via written reports and/or open discussions in audit wrap-up meetings.
  • Follow up on audits to assure that action plans are developed and completed in a timely fashion.
  • Keep current with all regulatory requirements and disseminate and interpret all regulatory requirements to plant personnel in a timely and accurate fashion.
  • Consult with plant personnel on regulatory requirements and compliance related topics.
  • Responsible for management review and associated metrics for the plant
  • Administrate/coordinate the plant manufacturing materials and pest control programs.
  • Coordinate and facilitate major plant quality improvement projects at the plant or company level.
  • Perform process of metrics collection and analysis for compliance-related corrective and preventive actions (CAPA's).

  • Bachelor's Degree, preferably in Science or Engineering, or equivalent related work experience is required.
  • 3+ years of Biopharmaceutical experience
  • Quality Assurance/Regulatory Affairs/Compliance experience required
  • Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
  • Able to demonstrate extensive knowledge of plant and company level procedures.
  • Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
  • Strong decision making
  • Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve

Equal Opportunity Employer Minorities/Women/Veterans/Disabled