Compliance Specialist I

Job Description

Job Description

Salary : JOB SUMMARY

The Compliance Specialist has oversight responsibilities for the internal and external auditing programs. This includes hosting 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

RESPONISIBILITIES

• 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

REQUIREMENTS AND QUALIFICATIONS

OTHER REQUIRED

SKILLS