EMPLOYMENT

EMPLOYMENT

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.