Position Summary:

The purpose of this position is to review procedural documentation, conduct routine equipment checks and assist the quality assurance department during audits and inspections.

Responsibilities:

The essential functions of the position include, but are not limited to:

• • • • Assist QA Manager in the drafting, planning, and implementation of all quality programs, projects, process and/or activities to ensure quality products/services are regulatory compliant;
• Assist the Quality Assurance Manager for adherence to all laboratory procedures and policies, while performing oversight functions and reviews of laboratory operations.
• Manage or assist with the management of the equipment qualification, calibration and maintenance program.
• Review procedures, protocols and other technical documents for format and proper template usage.
• Perform routine calibrations and performance checks for supporting equipment (balances, pipettes, thermometers, etc.)
• Implement governed corrective and preventative actions derived from nonconformance reports, internal/external audits, or facility inspections.
• Complete required quality questionnaires from customers as needed.
• Assist with the approval and monitoring of all suppliers and contract (third party) vendor activities.
• Assist the QA department with all customer audits and inspections.
• Assist with Federal (FDA and OSHA), State, local, and third-party audits.
• Conduct internal audits in conjunction with QA and management.
• Participate in Management Review meetings.
• Participate in weekly QA remediation meetings.

Requirements:

The minimum education and background experience needed for this position are:

• • • • BA/BS degree preferred, Associates degree required.
      • Some laboratory experience and/or understanding of cGMP GLP GDP.
      • Proficiency in Microsoft Word and Excel; excellent typing speed preferred.
      • Strong organizational skills, both physically and electronically.