Quality Assurance Laboratory Manager

Job Description

Job Description

Seeking a Quality Assurance Manager to oversee laboratory quality standards and regulatory compliance, ensuring alignment with the company's mission and objectives. This role provides proactive leadership, identifying improvement opportunities and fostering a culture of continual excellence in quality and laboratory procedures.

Key Responsibilities:
Quality Management System Leadership

• Coordinate and maintain the laboratory's Quality Management System with support from the Laboratory Director, Laboratory Manager, Group Leaders, and laboratory staff
• Manage document control, quality records, and training documentation
• Oversee internal and external audits, corrective and preventative actions
• Coordinate proficiency testing scheduling, reporting, and follow-up
• Ensure supplier qualification and traceability
• Serve as archivist for GLP study-specific records

Compliance & Auditing

• Conduct internal audits of the quality management system at least annually to maintain compliance with appropriate standards and accreditation programs
• Identify areas of non-conformance and opportunities for improvement
• Perform procedural audits of laboratory methods against SOPs, LABs, and regulatory requirements
• Verify new method validations and improvements comply with policies and regulatory requirements

Documentation & Reporting

• Write and maintain quality management system SOPs and documentation
• Prepare special reports for regulatory agencies and clients (FDA data packages, ODA data packages, external audit responses)
• Compile and prepare the annual Management Review of the Quality System Report
• Make periodic reports to Laboratory Management on quality performance and audit details

Training & Communication

• Coordinate and conduct quality assurance training for laboratory personnel
• Conduct laboratory meetings to communicate operational information, regulatory updates, and quality improvements
• Coordinate Annual Quality Review Meetings with Laboratory Management

Additional Duties

• Coordinate and manage verification and maintenance of laboratory equipment calibration schedules
• Assist with sales and marketing to existing and potential clients on QA-related inquiries
• Supervise QA Associate/Assistant positions, including hiring, training, performance appraisals, and work assignments

Qualificaitons:

• Bachelor's degree (B.S.) in Chemistry or relevant science from a four-year college or university or equivalent combination of education and experience
• 2+ years of QA experience in regulatory compliance, preferably ISO 17025, NELAC, and/or GLP
• Previous laboratory experience preferred
• Advanced mathematical abilities, including exponents, logarithms, quadratic equations, statistical analysis, and variance analysis
• Proficient in quality assurance/quality control evaluation procedures and audits
• Technical writing experience for manuals and documentation
• Highly competent user of MS Office

Preferred Qualifications:

• Registered Quality Assurance Professional (RQAP) certification
• Registered Quality Assurance Professional for GLP regulations (RQAP-GLP)
• Laboratory analytical experience
• Experience working in international businesses with cultural awareness

\nCompany Description

Real People. Real Connections. Real Results.

That's the Messina Talent Advantage.

For more than 40 years, Messina's Talent practice has continuously evolved to meet the needs of our clients. We not only help our clients fill roles and build their teams, but we also help them better understand their workforce and develop strategic talent initiatives that drive value for their organizations.

Messina Talent Advisors, a Messina Group Company, has the network, proven processes, and all the latest technologies to connect the right candidates with the right jobs - faster.

Company Description

Real People. Real Connections. Real Results.\r\n\r\nThat's the Messina Talent Advantage.\r\n\r\nFor more than 40 years, Messina's Talent practice has continuously evolved to meet the needs of our clients. We not only help our clients fill roles and build their teams, but we also help them better understand their workforce and develop strategic talent initiatives that drive value for their organizations.\r\n\r\nMessina Talent Advisors, a Messina Group Company, has the network, proven processes, and all the latest technologies to connect the right candidates with the right jobs - faster.