Compliance Auditor

Grifols; Los Angeles (CA); Remote; USD 75,000 - 110,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Compliance Auditor to ensure adherence to regulatory standards and operational effectiveness. This role involves conducting audits, preparing detailed reports, and interacting with various stakeholders to improve compliance systems. Ideal candidates will have a solid background in quality assurance and regulatory compliance. The position requires travel within the US and Canada.

Qualifications

• Bachelor's degree highly preferred; equivalent experience may be considered.
• Typically requires 5 years of related experience in blood collection/testing, storage, and distribution.
• Experience in SOP development, quality control principles, and QA audits.

Responsibilities

• Oversee compliance and quality audits of donor centers and suppliers.
• Evaluate facility performance and prepare reports for stakeholders.
• Analyze post-audit reports and recommend improvements.

Skills

Audit Skills

Regulatory Compliance

Reporting and Presentation Skills

Analytical Skills

Education

Bachelor's degree

Equivalent experience

Tools

Microsoft Office

Job description

Join to apply for the Compliance Auditor role at Grifols.

Oversee and conduct compliance and quality audits of donor centers, warehouses, transportation, labs, and other suppliers of services and goods. Inspect for compliance with regulatory and customer requirements, Standard Operating Procedures (SOP), and current Good Manufacturing Practices (cGMP).

Primary Responsibilities

• Assess facility compliance with SOPs, applicable domestic and international regulatory agencies such as FDA and EMA, and federal and state regulations.
• Evaluate overall facility performance regarding operations, organization, employee training, and cleanliness.
• Prepare and present electronic reports of inspection findings to relevant stakeholders.
• Interact with facility management to ensure understanding of audit findings.
• Provide support and suggestions for improving systems and compliance.
• Analyze reports from facilities post-audit and evaluate corrective actions.
• Manage multiple tasks with competing demands and deadlines.
• Interface with various organizational levels and groups.
• Assist in developing or revising procedures based on audit trends and findings.
• Proficient in Microsoft Office, with strong reporting and presentation skills.
• Travel required; this is a remote position.

Education and Experience

• Bachelor's degree highly preferred; equivalent experience may be considered.
• Typically requires 5 years of related experience in blood collection/testing, storage, and distribution.
• Experience in SOP development, quality control principles, and QA audits.
• Expertise in SOPs, cGMPs, FDA, CLIA, IQPP, and European regulations.

Occupational Demands

Travel 50% within the US and Canada; work in an office environment; frequent sitting; occasional walking, bending, lifting (up to 25 lbs), and driving.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Finance and Sales
• Industries: Pharmaceutical and Medical Equipment Manufacturing