QA Compliance Coordinator

The Compliance Coordinator has primary oversight responsibilities for the internal and external auditing programs. This includes hosting of audits from clients and regulators, including audit preparation and follow-up activities. The Compliance Coordinator also acts as lead investigator for audits conducted by Boston Analytical (e.g. internal and supplier audits).

Primary Duties and Responsibilities

  • Oversight of the internal audit program for both GMP and ISO compliance.
  • Generation of the internal audit schedule.
  • Coordinate audit activities with applicable departments.
  • Track audit activities and follow-up requirements.
  • Work with QA Management to determine acceptance of audit responses.
  • Scheduling and hosting of client and regulatory audits/inspections.
  • Audit preparation activities.
  • Hosting of audits.
  • Authoring audit responses and coordinating associated activities.
  • Schedule audit activities to align with supplier qualification program requirements.
  • Work with QA Management to determine acceptance of audit responses and questionnaires.
  • Perform routine review of suppliers.
  • Lead supplier auditing program.

Requirements & Qualifications:

Qualification include a Bachelor’s degree in a related discipline with 5+ years with a combination of QA/QC and auditing experience in the pharmaceutical industry. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production. Experience in root cause analysis, risk management, and corrective/preventative action development.

Minimum Skills Requirements:

  • Enthusiastic, team player, collaborative across all departments to achieve the common goals.
  • Ability to focus on internal processes while maintaining focus on client needs.
  • Ability to work in a fast paced, dynamic environment.
  • Experience with LEAN implementation.
  • Familiarity with laboratory information management systems (LIMS).
  • ISO 17025 or 9001 experience and knowledge.
  • Demonstrated ability to foster a Quality Culture across the organization.
  • Lead Auditor experience and/or CQA certification.