Supplier Compliance Auditor

ZipRecruiter; Rockville (MD); On-site; USD 125,000 - 150,000; Full time

Job summary

A well-established life sciences management consulting firm is seeking a Supplier Compliance Auditor with expertise in laboratory practices. The role entails conducting quality audits focusing on sedimentation velocity analytical ultracentrifugation (SV-AUC) to ensure regulatory compliance. Ideal candidates will possess a strong background in laboratory auditing and analytical techniques, contributing to the firm's mission of supporting various organizations in the biotech and pharma sectors.

Qualifications

• Experience with Quality Auditing is a must.
• Relevant analytical experience in a laboratory setting with SV-AUC is essential.
• Knowledge of GLP and quality assurance practices.

Responsibilities

• Conduct compliance-quality audits of laboratory practices focused on SV-AUC.
• Evaluate quality management systems and regulatory compliance.
• Prepare comprehensive audit reports detailing findings.

Skills

Quality Auditing

Analytical Skills

Attention to Detail

Education

Bachelor's degree in Biochemistry, Biophysics, Chemistry, or related field

Job description

Job DescriptionJob Description

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.

Job Summary:
Tunnell is seeking a knowledgeable Quality Auditor with analytical experience to conduct a compliance-quality audit of laboratory practices, specifically focusing on sedimentation velocity analytical ultracentrifugation (SV-AUC). The auditor will evaluate the quality of testing processes, data integrity, and adherence to regulatory standards on behalf of our client.

Job Title: Supplier Compliance Auditor for Contract Testing Laboratory

Location: Greater Baltimore, MD area.

Duration: One-day audit

Job Summary:
Tunnell is seeking a knowledgeable Quality Auditor with analytical experience to conduct a compliance-quality audit of laboratory practices, specifically focusing on sedimentation velocity analytical ultracentrifugation (SV-AUC). The auditor will evaluate the quality of testing processes, data integrity, and adherence to regulatory standards on behalf of our client.

Key Responsibilities:

1. Audit Preparation:

• Review relevant protocols, standard operating procedures (SOPs) according to regulatory guidelines (FDA and EMA) criteria.
• Identify specific compliance areas for focus during the audit based on client requirements.
• Prepare Audit agenda.

On-Site Observations:

• Perform facility tour to observe sample receipt, handling and storage processes.
• Observe SV-AUC experiments in real-time to ensure adherence to established methodologies and GLP.
• Evaluate the setup, operation, and maintenance of analytical instruments related to SV-AUC.

Data Review:

• Analyze experimental data generated from SV-AUC to verify accuracy and compliance with expected results.
• Ensure proper documentation standards are met for recording and reporting results.

Quality Assessment:

• Evaluate the overall quality management systems in place, including sample handling, instrument calibration, and data management practices.
• Ensure overall compliance with regulatory standards and industry best practices.
• Provide constructive feedback on any compliance issues or areas requiring improvement identified during the audit.

Reporting:

• Prepare a comprehensive audit report detailing findings, highlighting areas of strength and non-compliance.

Education/Experience:

• Bachelor's degree or higher in Biochemistry, Biophysics, Chemistry, or a related field.
• Experience with Quality Auditing a must.
• Relevant analytical experience in a laboratory setting is essential, with hands-on experience in SV-AUC being a strong plus.
• Experience with size exclusion chromatography (SEC) is also advantageous.
• Knowledge of quality assurance practices and regulatory compliance (GLP) in laboratory environments.
• Excellent observational and analytical skills, with high attention to detail.
• Relevant certifications in laboratory compliance an asset.

Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to , , , , , , , , or status as a protected veteran.

Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.