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.
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