Compliance Specialist I na Boston Analytical

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

• Qualifications 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.

OTHER REQUIRED
SKILLS

• Enthusiastic, team player, collaborative across all departments to achieve the common goals.
• Ability to focus on internal processes while maintaining focus on client needs.