Auditor

Samsung Biologics is seeking an Auditor to support our Rockville, MD site. This role is responsible for managing internal audit programs and external supplier audits, while ensuring compliance with cGMP standards and regulatory requirements.

Key Responsibilities

• Lead and manage internal (Business Management) audits and external supplier audit programs.

• Serve as an auditor for site internal audits and supplier audits.

• Develop and maintain the annual audit plan, including facilitating periodic review meetings with management.

• Conduct audit close-out meetings to communicate findings and expectations to stakeholders.

• Prepare, issue, and maintain internal and supplier audit reports using standardized formats.

• Review audit responses for adequacy, identify gaps, and work with owners to resolve discrepancies.

• Coordinate and track CAPAs (Corrective Actions) associated with audit findings to ensure timely completion.

• Monitor audit commitments and ensure adherence to established response timelines.

• Generate and distribute monthly reports on outstanding audit commitments and CAPA status.

• Perform follow-up activities to verify implementation and effectiveness of corrective actions.

• Provide guidance to site personnel on cGMP compliance and regulatory expectations.

• Support preparation for regulatory inspections, corporate audits, and customer audits.

• Assist with audit observation follow-up related to regulatory inspections and global quality audits.

• Interpret and communicate current regulatory requirements and industry guidance to internal stakeholders.

• Collect, analyze, and report site Quality metrics and support quality trending activities within required timelines.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field)

• Experience in a cGMP-regulated environment (biopharmaceutical industry preferred)

• Strong knowledge of auditing practices and CAPA management

• Familiarity with FDA and global regulatory expectations