GLP QA Auditor II: Regulatory Compliance & Audits

Inotiv; Rockville (MD); On-site; USD 61,000 - 80,000; Full time

Job summary

Inotiv, a leading global contract research organization, seeks a Quality Assurance Auditor II in Rockville, MD to audit studies and facilities for GLP compliance, prepare audit reports, and maintain SOPs and regulatory knowledge.

Required: a B.S. in chemistry or life sciences with 2–4 years in GLP environments, strong communication, problem solving, and the ability to work independently. Salary range: $60,600–$79,900; benefits include health and more.

Qualifications

• B.S. in chemistry or life sciences or related field.
• 2–4 years of experience in a GLP or regulated environment, preferably with auditing experience.
• Equivalent combination of education and regulatory, quality, compliance and/or industry experience.

Responsibilities

• Audit studies and facilities to assess compliance with protocols, SOPs, and regulations.
• Prepare audit reports and submit findings to Study Director/PI and management.
• Maintain knowledge of facility SOPs, policies, study protocols, and regulatory requirements.
• Provide QA training for new hires and other staff as assigned.
• Participate in subcontractor and vendor evaluations and regulatory projects.

Skills

GLP auditing experience

Regulatory compliance knowledge

Analytical problem solving

Excellent written and verbal沟通

Independent work

Attention to detail

Team collaboration

Computer proficiency

Education

Bachelor's degree in chemistry or life sciences

Equivalent combination of education and experience

Tools

Excel

SharePoint

Word

Outlook

Job description

Inotiv, a leading global contract research organization, seeks a Quality Assurance Auditor II in Rockville, MD to audit studies and facilities for GLP compliance, prepare audit reports, and maintain SOPs and regulatory knowledge.

Required: a B.S. in chemistry or life sciences with 2–4 years in GLP environments, strong communication, problem solving, and the ability to work independently. Salary range: $60,600–$79,900; benefits include health and more.