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About SNBL USA, Ltd.:
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SNBL USA, Ltd. is a leading contract research organization located just 30 minutes from Seattle, in Everett, WA. Through a commitment to investment and excellence, our team is able to offer the biotechnology and pharmaceutical industries high quality science and service. We have 275 employees and are continuing to expand with 100,000 sq ft of lab and office space to be completed the second quarter of 2006. Our organization is fueled by the talent of a diverse team of SNBL employees.
Click here to go to the SNBL USA, Ltd. website.
For details about SNBL USA, Ltd., click here.
About the Opportunity/Requirements:
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QUALITY ASSURANCE ANALYTICAL AUDITOR
SNBL USA is a contract scientific research company providing pre clinical research services to biotech and pharmaceutical clients throughout the world. Our Company has 385 employees at two locations and is continuing to grow. SNBL USA strives to provide the highest quality research and science by encouraging an environment where our employees can generate their own personal successes, one day at a time.
The Quality Assurance Analytical Auditor will perform a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits, data and documentation reviews and analysis. Coordinate auditing activities and implement auditing systems to ensure compliance with GLP requirements by performing the following duties:
• Maintaining Good Laboratory Practices (GLP).
• Maintaining computerized files to support audit activities.
• Performing critical phase inspections of ongoing analytical study activities.
• Audits GLP analytical reports, raw data and supporting documentation for internal accuracy, consistency, and conformance with regulations.
• Audits GLP Method Validations for internal accuracy, consistency and conformance with regulations.
• Prepares, issues and tracks reports of observations noted during audits and inspections.
• Supports project planning and implementation; acts as lead auditor on analytical portions of studies.
• Regularly applies best practices and GLP principles to issues.
• Identifies compliance gaps in processes, systems and studies; provides risk-based compliance opinions and guidance.
• Influences and collaborates with employees and management; assists with representing QA in internal work groups.
• Assists in designing training systems; trains employees on internal procedures.
• Performs annual facility audits to ensure departmental compliance with the regulations.
• Audits studies for consistency and compliance with the regulations.
• Reviews and updates Quality Assurance SOPs to ensure reflection of current practice.
• Assists with training of SNBL USA staff by conducting training seminars and distributing information on GLP regulations and other related standards.
Education and Experience:
• Bachelor of Science and 3+ years experience in a Quality Assurance environment (e.g. GLP, GMP, FDA, EPA or OECD) within the biotech, pharma, or the medical industries.
• Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality – Certified Quality Auditor) or other certification is preferred.
SNBL USA, Ltd. is a drug-free workplace. Pre-employment drug test required.
SNBL USA, Ltd. offers a competitive compensation and benefits package including health, dental, vision, pharmaceutical, life, and disability insurances, 401(k), Section 125, and a generous PTO package.
Please submit resume and cover letter to: hr@snblusa.com
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