What We're Looking For

The Quality Assurance Manager is responsible for providing leadership, support, and guidance to the Quality unit from a regulatory point of view The Manager will oversee and promote quality principles to ensure product quality, regulatory compliance, customer satisfaction, and corporate objectives are met. 

What You Will Do

• Responsible for creating an environment that encourages compliant efficiency, developing and coaching technical staff to improve skills, and ensuring high quality technical work.

• Supervise the daily testing and documentation review of raw materials to ensure accuracy and completion.

• Create/Update/Review Standard Operating Procedures (SOPs)

• Conduct investigations (for internal and external customers), as well as provide guidance to team members on identifying root causes, while maintaining the highest safety, quality and GMP standards 

• Works interdepartmentally to identify corrective and preventative actions for deviations/out of specification reports.

• Maintain knowledge of industry trends by attending trainings, reading journals, books, and other appropriate literature

• Work with the Operations management team to ensure quality and regulatory compliance concerns/issues are addressed.

• Review, analyze, and trend various quality defects and formulate quality remediation recommendations.

• Manage controlled quality and regulatory documentation.

• Communicate quality data and trends to strategic management.

• Oversee management of complaints – investigate, provide corrective action, and issue reports of findings and trends.

• Ensure corrective actions are properly implemented and operate effectively.

• Handle recalls and host FDA and DEA inspections

• Manage audits and the quality systems to ensure company compliance and to maintain and improve customer satisfaction. 

• Ensure that department objectives are in line with corporate objectives.

• Ensure compliance with company policies and all applicable SOPs; cGMPs, cGLPs, A2LA requirements and Quality Control Guidelines ISO 17025 guidelines are followed throughout the laboratory.

• Assist with related special projects, as assigned.

Who You Are

• Master’s Degree in a Biological Sciences field (specialized in Microbiology and/or Analytical Chemistry) with 10 years of QA experience in GMP facility or bachelor’s degree with 15 years of experience.

• At least five years of direct management experience.

• Thorough knowledge of Good Manufacturing Practices (cGMPs), 21 CFR 210 & 211, A2LA requirements, and ISO 17025 guidelines

• Advanced knowledge of statistics, quality metrics and trending applications 

• Excellent leadership and customer service skills

• Assertive and advanced skills in effective written and verbal interdepartmental communication 

• Ability to think analytically, solve problems and provide resolution to conflicts (i.e., quality issues with operations)

• Ability to work in a collaborative team environment.

• Advanced level computer skills in Microsoft Word, Excel, Outlook, and management systems

• ASQ certification preferred.

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.