Quality Assurance Auditor II – GLP Compliance & Audits

BASI GAITHERSBURG LLC; Rockville (MD); On-site; USD 61,000 - 80,000; Full time

Benefits offered by this job

Health and dental coverage

Disability insurance

Paid time off

Parental leave

401K

Job summary

Inotiv in Rockville, MD is seeking a Quality Assurance Auditor II with a B.S. in chemistry or life sciences and 2–4 years in GLP environments, including auditing experience.

The role requires strong regulatory knowledge, precise documentation, and the ability to work with cross-functional teams. Responsibilities include conducting audits, preparing reports, maintaining SOPs, and ensuring compliance with FDA and EPA GLPs and international standards.

Qualifications

• B.S. in chemistry or life sciences or related field with 2–4 years GLP or regulated experience.
• Preferably 1+ years of auditing experience or equivalent regulatory/quality exposure.

Responsibilities

• Conduct audits of designated studies and facilities for compliance with protocols and SOPs.
• Prepare audit reports and communicate findings to study directors and management.
• Maintain knowledge of facility SOPs, policies, and study protocols.
• Perform quality training for new hires and other staff as assigned.
• Represent QA in regulatory topics and participate in projects.

Skills

Excellent communication

Interpersonal skills

Organizational skills

Attention to detail

Independent work

Regulatory interpretation

QA proficiency

Root cause analysis

Quality systems knowledge

Education

Bachelor's degree in chemistry or life sciences

Tools

Word

Outlook

Excel

SharePoint

Job description

Inotiv in Rockville, MD is seeking a Quality Assurance Auditor II with a B.S. in chemistry or life sciences and 2–4 years in GLP environments, including auditing experience.

The role requires strong regulatory knowledge, precise documentation, and the ability to work with cross-functional teams. Responsibilities include conducting audits, preparing reports, maintaining SOPs, and ensuring compliance with FDA and EPA GLPs and international standards.