QA Compliance Specialist

The Compliance Specialist has 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 Specialist 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
  • Lead supplier auditing program
    • 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


Qualification include a Bachelor’s degree in a related discipline with 3+ 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.