Prometheus Laboratories is a forward-thinking clinical diagnosticscompany that is dedicated to disrupting the treatment paradigm of GI and autoimmune diseases. We do this by discovering and developing a broad portfolio of novel, precision-based diagnostic testing solutions that meaningfully impact patient care throughout their individual healthcare journey. From patient-personalized diagnosis and prognosis, disease profiling, therapeutic selection through disease monitoring, the Prometheus suite of tests is purpose-built to take the guess work out of critical patient care needs. Our ambition is to expand our team with like-minded leaders with shared passion and dedication for transforming the future of precision-guided patient care.
Responsible for promoting a quality mindset across an entire company. Working with cross-departmental leadership to deliver high quality testing services and streamline operations. Establish and maintain a quality system to ensure a company's facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and regulatory standards.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Assures quality testing and processes by establishing and enforcing quality standards and testing materials and products.
- Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with operators, CLSs. technicians, and customer service.
- Creates quality documentation system by writing and updating quality assurance procedures.
- Maintains quality by enforcing quality assurance policies and procedures and government requirements.
- Collaborates with other members of management to develop new product and designs.
- Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
- Leads the trending and metrics programs for Quality Systems; assess each functional area for trends and opportunities for improvement.
- Ensures a robust CAPA program is in place with timely process for toot cause analysis, verification of actions and effectiveness checks.
- Develops a quality assurance staff by recruiting, selecting, orienting, and training employees.
- Ensures quality by planning, monitoring, and appraising job results.
- Leads the process for reporting, investigating and trending customer complaints. Ensure procedures are established to identify if a complaint is reportable under regulations and document the decision process.
- Facilitates or supports inspections by regulatory authorities and maintain a state of inspection readiness. Participate in the development of responses to agency observations or deficiencies and ensure CAPAs are completed timely with appropriate effectiveness verification.
- Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
- Achieves financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
- Supervisors electronic document control systems.
QUALIFICATIONS & SKILLS
EDUCATION & EXPERIENCE
- Experience in a CLIA/CAP Laboratory a must
- Strong written and verbal communication skills
- Analytic skills
- Collaboration skills
- Product management skills
- QA process skills
- Computer knowledge and skills
- BA or BS degree in appropriate discipline
- Seven to 10 years' experience in a similar role
- California Clinical Laboratory License preferred
- CLIA / CAP inspector experience a plus
- Knowledge of safety requirements and legal standards
- Working knowledge of quality system requirements
- Experience with MS Word, Excel, MasterControl
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.