Quality Site Administrator

Quality Site Administrator

Under limited direction, this position is responsible for the overall management of the Analytics and Result Review Quality Assurance teams for a specific laboratory location. The Quality Site Administrator monitors and evaluates the quality system for compliance with applicable regulations, improvement initiatives, and business needs. This role closely partners with laboratory operations teams to ensure the laboratory meets current production requirements in a manner compliant with laboratory quality standards and current regulatory guidelines.

Primary duties and responsibilities include managing the Quality Assurance (QA) team for a specific laboratory location, ensuring appropriate staffing, development, training, and problem resolution across two or more shifts, planning and analyzing workflow, managing and escalating quality and compliance issues, managing laboratory tracking and trending data collection, leading the error management program, performing follow-up on audit observations, leading and participating in process design activities, participating in review teams to evaluate nonconforming products, materials, or test results, advocating and leading annual and quarterly objectives, assisting in the oversight of Clinical Trial Studies, championing OE culture within areas of responsibility, implementing and maintaining appropriate leading and lagging indicators, facilitating and coordinating the CAPA program, ensuring the analytic and result review processes meet regulatory standards and business needs, acting as host and primary liaison for external and internal inspections/audits, managing and facilitating recalls and market withdrawals, performing review of documents as defined by CTS systems to ensure control of processes and adherence to cGMP requirements, assuring quality customer service to all customers, performing all assigned duties in compliance with internal SOPs and external regulations, and performing all other duties, at the discretion of management, as assigned.

Required qualifications include a Bachelor's degree in science or quality related field, at least five (5) years related experience in quality assurance in a Biological/Pharmaceutical environment, previous supervisory or management experience, and previous project or technical leadership. Preferred qualifications include CMQOE, CQA, RAC, or Six Sigma certification.

Skills and abilities include excellent leadership and people management skills, ability to be organized and efficient, excellent communication and influencing skills, proven track record of successfully implementing quality initiatives and driving continuous improvement, ability to demonstrate practical applications and flexibility in adapting programs and services to meet specific requirements, ability to organize, prioritize, and execute a variable workload and multiple priorities, ability to work flexible hours to support a 24/7 work environment, ability to contribute to development and company objectives to achieve goals in creative and effective ways, proficient computer skills, and ability to apply abstract principles to solve complex conceptual issues.

Physical and travel requirements include lab work environment with exposure to biological fluids, extreme cold, production chemicals, moving machinery and production equipment, high levels of noise, personal protective equipment required, travel less than 15%, and physical activities such as sitting, standing, handling, walking, climbing, bending, squatting, reaching, grasping items, and carrying/moving/lifting items up to 35 pounds.