QA Manager - Laboratories

Onterris•Durham, NC

2d•$75,000 - $105,000•Onsite

About The Position

As a QA Manager, this is a pivotal leadership role in our laboratory, responsible for overseeing, proactively managing, and continuously improving the Quality Management System. Key responsibilities include ensuring compliance with standards, retaining and expanding accreditations, adhering to analytical methods and regulatory standards, overseeing document control, managing internal and external audits, and improving laboratory protocols and documentation. The QA Manager also plans and leads initiatives to drive continuous improvement of laboratory processes. The compensation range for this role is $75,000.00 to $105,000.00, commensurate with experience, skills, and geographic location. Schedule: Monday - Friday. To thrive in this role, you’ll be comfortable taking ownership of the following responsibilities: As the focal point for all quality initiatives, the QA Manager establishes and upholds quality standards while fostering a culture of continuous improvement. Operating independently of production operations and financial responsibilities, this role focuses on maintaining high-quality standards and operational efficiency. A deep understanding of safety and environmental laboratory practices and protocols is essential. The Manager leads the quality assurance team, equipping them to perform effectively and aligned with organizational goals. The Director is responsible for: Leading the quality assurance team by fostering a culture of responsiveness, leadership, and continuous improvement. Mentoring and guiding staff to enhance performance and support their professional growth. Partnering with the Laboratory Director and Operations Managers to identify inefficiencies and implement solutions. Leading cross-functional change initiatives to optimize processes. Upholding the highest standards of ethics, integrity, and professionalism, ensuring confidentiality and discretion when handling sensitive company, personnel, and client information. Strategically managing laboratory accreditations, monitoring regulatory updates, and maintaining relationships with accrediting bodies while ensuring compliance with regulatory standards (e.g., TNI). Administration of the proficiency testing program, evaluating results, and collaborating with operations to develop corrective actions for any failures identified. Overseeing the laboratory’s QA/QC and data integrity improvement activities. Ensuring standard operating procedures are accurate, well-organized, technically sound, aligned with operational goals, and compliant with applicable standards. Overseeing personnel training records (e.g., demonstration of capability), ensuring completion, documentation, and evaluation for conformance to applicable requirements. Planning, conducting, and documenting internal audits and data assessments. Scheduling and hosting external audits by third-party assessors, clients, and accrediting body representatives. Addressing nonconformances and deficiencies, providing actionable insights to laboratory leadership while planning, implementing, and addressing corrective actions. Managing corrective and preventative actions by utilizing root cause analysis tools to document, resolve, and monitor outcomes effectively to prevent reoccurrence. Collaborating with the operations team to evaluate and implement efficiency, accuracy, and safety improvements. Leading the development and execution of operational goals, efficiency plans, and enhancing the QA program and the QA Manual by integrating best practices such as statistical control and risk-based approaches. Developing and delivering QA/QC training to engage staff and promote compliance with ethical standards. Documenting validations of new test and measurement services. Developing and monitoring QA performance indicators, reporting findings to management, and identifying areas for improvement. Completing standard reporting requirements and ensuring compliance with health and safety plans to promote and maintain a secure working environment.

Requirements

Bachelor’s degree in chemistry, biology, environmental science, or related field
A minimum of five (5) years of relevant QA/QC experience in an accredited environmental laboratory, with a minimum of two (2) years in a leadership role such as Group Leader, Project Manager, or comparable experience that provides the knowledge, skills, and abilities to perform the job.
Technical expertise in environmental testing methods, including method validation and data interpretation.
Proficient in root cause analysis, statistical tools, and Laboratory Information Management Systems (LIMS), with strong analytical and problem-solving skills.
Extensive working knowledge of industry regulations including USEPA, TNI 2016 Standard, 40CFR, and other regulated environments (e.g., DoD/DOE).
Proven leadership skills with experience mentoring staff, developing high performers, and driving quality initiatives.
Strong communication and interpersonal skills, with ability to liaise effectively with regulators, clients, and internal stakeholders.
Proficiency with Microsoft Office Suite (i.e., Excel, PowerPoint, Word, SharePoint, Teams).

Nice To Haves

Experience with quality management software is a plus

Responsibilities

Leading the quality assurance team by fostering a culture of responsiveness, leadership, and continuous improvement.
Mentoring and guiding staff to enhance performance and support their professional growth.
Partnering with the Laboratory Director and Operations Managers to identify inefficiencies and implement solutions.
Leading cross-functional change initiatives to optimize processes.
Upholding the highest standards of ethics, integrity, and professionalism, ensuring confidentiality and discretion when handling sensitive company, personnel, and client information.
Strategically managing laboratory accreditations, monitoring regulatory updates, and maintaining relationships with accrediting bodies while ensuring compliance with regulatory standards (e.g., TNI).
Administration of the proficiency testing program, evaluating results, and collaborating with operations to develop corrective actions for any failures identified.
Overseeing the laboratory’s QA/QC and data integrity improvement activities.
Ensuring standard operating procedures are accurate, well-organized, technically sound, aligned with operational goals, and compliant with applicable standards.
Overseeing personnel training records (e.g., demonstration of capability), ensuring completion, documentation, and evaluation for conformance to applicable requirements.
Planning, conducting, and documenting internal audits and data assessments.
Scheduling and hosting external audits by third-party assessors, clients, and accrediting body representatives.
Addressing nonconformances and deficiencies, providing actionable insights to laboratory leadership while planning, implementing, and addressing corrective actions.
Managing corrective and preventative actions by utilizing root cause analysis tools to document, resolve, and monitor outcomes effectively to prevent reoccurrence.
Collaborating with the operations team to evaluate and implement efficiency, accuracy, and safety improvements.
Leading the development and execution of operational goals, efficiency plans, and enhancing the QA program and the QA Manual by integrating best practices such as statistical control and risk-based approaches.
Developing and delivering QA/QC training to engage staff and promote compliance with ethical standards.
Documenting validations of new test and measurement services.
Developing and monitoring QA performance indicators, reporting findings to management, and identifying areas for improvement.
Completing standard reporting requirements and ensuring compliance with health and safety plans to promote and maintain a secure working environment.