SUMMARY:
Responsible for the implementation of and/or support of the implementation of the Quality Program, policies and procedures from a functional or technical perspective for multi-sites within the division. Provides advisement to management staff in quality-related matters, including performance, regulatory compliance, and data quality and usability. Areas are typically varied and complex to specialized in nature.
ESSENTIAL FUNCTIONS:
Supervises staff including hiring, training, evaluating performance, providing compensation recommendations, and performance management. Ensures the Quality Management System is understood, implemented, and maintained at all levels for each site assigned. Assists the Quality Manager to identify, prevent, and correct departures from the quality management system for each site assigned; oversees internal audits and may assist with corporate compliance audits. Promote communication on quality-related matters between site(s) assigned; promotes transparent and consistent sharing of information across the division. Coaches and mentors the quality manager for each site assigned. Reviews data related to The Quality System for trends and risks to identify opportunities for improvement for each site assigned; helps each site execute process improvement. Contributes to the writing and review of corporate and site-specific policy and standard operating procedure(s). Assists with the development of Quality Assurance Program training materials; conducts training on topics related to quality systems management and regulatory compliance. Works with laboratory management to resolve simple to complex matters related to quality, data integrity, and validity. Assists the Quality Manager, for each site assigned, achieves and maintains compliance to applicable Federal and State regulations, and program or client-specific requirements. Participates in the hiring process for Quality Assurance staff and makes recommendations for hire, trains or helps to train and develop Quality Assurance staff; resolves or helps to resolve personnel issues. Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team. Promotes and supports the overall mission of Pace by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.
QUALIFICATIONS:
Education and Experience:
Bachelor's degree in chemistry, biology, or a closely related field; AND five (5) years of professional experience in quality assurance and/or quality systems management; OR an equivalent combination of education, training, and experience.
Required Knowledge and Skills
Required Knowledge:
Principles and practices of quality system standards ISO/IEC 17025, TNI, and DoD/DOE QSM in a laboratory environment. Applicable federal and state regulations and certification/accreditation programs in a laboratory environment. Laboratory operations and QA/QC protocol in a regulatory environment. Computer applications related to the work, especially Microsoft Office Techniques for dealing with a variety of individuals, in person and over the telephone. Data sampling and statistical analysis techniques. Correct business English, including spelling, grammar, and punctuation.
Required Skills:
Applying initiative and leadership skills Applying sound reasoning, decision making, and problem-solving skills Communicating effectively in written and verbal form Coordinating multiple priorities and seeing projects through to completion. Using work planning and organization tools and software. Interpreting, applying and explaining applicable laws, codes, and regulations. Preparing reports, recommendations, and required documentation associated with programs and activities. Using initiative and independent judgment within established procedural guidelines. Contributing effectively to the accomplishment of team or work unit goals, objectives, and activities. Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.