Job Description

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.