Auditor

Samsung Biologics RKV; Rockville (MD); On-site; USD 100,000 - 133,000; Full time

Benefits offered by this job

13 paid holidays

Vacation time

401K match

Medical, dental and vision benefits

Job summary

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

You will lead site internal audits, develop the annual audit plan, track CAPAs, and prepare audit reports. A science degree and hands-on cGMP experience are required; Maryland onsite presence is expected.

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.

Responsibilities

• Lead and manage internal (Business Management) audits and external supplier audit programs.
• Audit site internal processes and supplier activities; prepare findings and assessments.
• Develop and maintain the annual audit plan with management review meetings.
• Close-out audit findings and track corrective actions (CAPAs) to completion.
• Prepare and distribute audit reports; monitor response timelines and metrics.
• Support regulatory inspections, corporate audits, and customer audits.

Skills

Auditing

CAPA management

cGMP

Regulatory knowledge

Internal audits

Education

Bachelor's degree in science

Job description

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

The anticipated salary range for this position in Maryland is $99,825 to $133,100 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.

Benefits

• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental and vision benefits effective day one of employment

Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.