Zoetis Reference Laboratories (ZRL) is currently seeking a full time Quality Specialist to assist the global Quality Team in oversight of quality in all areas of the clinical laboratories in the ZRL network (multiple locations). ZRL is a new and rapidly growing division of Zoetis Global Diagnostics and currently includes legacy Phoenix, ZN, and Ethos laboratories.
The primary responsibility of the Quality Specialist is to support development, implementation, and upkeep of ZRL’s quality program, which includes all standardized technical laboratory protocols, training and competency standards and protocols, a comprehensive data and document management system, all criteria and protocols that ensure acceptable performance of analyzers and technical procedures, management and correction/prevention of adverse events, and continuous improvement initiatives.
The successful candidate will have strong organizational and teamwork skills, a keen eye for detail, and a passion for ensuring quality results. This is a values-driven organization where service is priority.
• Assists in developing, implementing, and maintaining clinical laboratory QA plans, policies, and procedures (SOPs) in accordance with ZRL quality assurance guidelines.
• Supports data collection and analyses as pertains to analyzer installation and validation, routine analyzer performance, proficiency testing, and internal quality-related studies.
• Continuously monitors policies and procedures to ensure the clinical laboratory meets ZRL quality standards.
• Supports the development and oversight of laboratory-based metrics to measure efficacy of the quality system and provide visibility for management oversight; ensures quality system robustness through internal audits/investigations, evaluations, process implementation, and continuous improvement opportunities.
• Supports oversight of the total life cycle of controlled documents from creation through approval and review in the document management system; collaborates with key stakeholders in meeting document management deadlines set by the ZRL Quality Team.
• With other members of the Quality Team, reviews and documents nonconforming events, conducts investigations, performs root cause analyses, develops corrective and preventive actions, and accurately documents effectiveness of the corrective action and/or preventative action.
• Assists with project management for assignments, such as gap analysis, risk management, document control, audits, inspections, process creation and improvement as needed; opportunity for travel likely.
• Collaborates with the ZRL Clinical and Operations teams to develop minimum standards of training and competency for all ZRL technical staff.
• Assists the ZRL Operations team in evaluating employee training and competency; collaborates with ZRL Operations for implementation and oversight of corrective and/or remedial training for technical staff.
• Bachelor’s degree (B.S. in chemistry or biology desired), although exceptions may be made for special circumstances
• Additional training or certification in laboratory quality assurance, quality management systems, lean six sigma highly desired
KNOWLEDGE AND EXPERIENCE:
• Proficient in Microsoft Office Suite (Word, PowerPoint, and Excel)
• Proficient in laboratory statistical programs (e.g., EP Evaluator) desired
• Minimum 3 years diagnostic laboratory experience with focused experience in quality assurance, experience in a regulated laboratory environment and/or veterinary experience preferred
• Commitment to ensuring high quality service and results
• Good interpersonal skills; should have proven skills as an effective team player
• Ability to work independently, including setting and meeting reasonable deadlines, but also able to recognize when additional support or resources are needed
• Professional presence
• Good verbal and written communication skills with strong analytic and problem-solving abilities
• Strong technical writing skills
• Excellent organizational skills and attention to detail