Overview
Stanford Health Care is seeking a Quality Assurance professional in Technical Services at the Stanford Blood Center. Under the supervision of the Technical Services Director, this role performs quality assurance duties including writing / revising validation plans, managing preventive maintenance, training records, audits, and regulatory compliance. The position may involve tasks related to processing and releasing blood products and communicating test results to hospitals and regulatory entities.
What You Will Do
- Write / revise / review equipment and process validation plans, test cases, and procedures; ensure annual reviews for SOPs, forms, and labels.
- Prepare training binders and schedules for new staff; ensure completion of training documentation (Healthstream and SBC SOPs); ensure competency assessments are completed on time; maintain training records.
- Review department records for accuracy under regulatory guidelines; manage the equipment preventive maintenance program and enter new equipment into the quality system.
- Review / discard / release blood products from quarantine; perform notifications for infectious disease exposure to hospitals / customers; complete PDIF and related test result checklists.
- Write, revise, review, schedule, and perform audits of laboratory and computer processes to verify compliance with procedures.
- Perform root cause analysis for events, determine corrective actions, monitor trends, and initiate process improvements; ensure timely event reporting and corrective action plans.
- Participate in Safety Committee activities; conduct inspections for Health and Safety compliance; act as department inspector during internal and external inspections.
- Initiate and route change controls for departmental projects; lead quality assurance meetings in supervisor's absence.
- Monitor and maintain equipment maintenance in the department; track and trend problem equipment; ensure privacy and security of sensitive information.
- May require entering areas with human blood and potential exposure to bloodborne pathogens.
Education & Experience
Education : High School Diploma or GED required; Associate's Degree preferred; Bachelor's Degree preferred.Experience : 7+ to 10 years in GMP environments with High School diploma; 5+ to 7 years with Associate's degree; 1+ to 2 years with Bachelor's degree.Knowledge, Skills & Abilities
Ability to train staff; strong quantitative and qualitative data analysis; working knowledge of cGMP;Excellent organizational and detail-oriented skills; ability to manage competing priorities;Strong written and oral communication; ability to explain technical concepts to diverse audiences;Ability to interpret government requirements and work independently.Licenses & Certifications
None.Physical Demands & Work Environment
Frequent sitting; occasional walking, standing, bending, squatting, kneeling; constant hand use and repetitive motions; keyboarding; occasional grasping, pushing, pulling, reaching.Frequent lifting up to 10 lbs; occasional lifting up to 40 lbs; drive / operate in various department areas as needed.Equal Opportunity
Stanford Health Care is an Equal Opportunity Employer. SHC values diversity and does not discriminate based on race, color, sex, sexual orientation or gender identity, religion, age, national origin, ethnicity, marital status, medical condition, genetic information, veteran status, or disability. Qualified applicants with criminal convictions will be considered after individualized assessment.
Base Pay Range : Generally starting at $39.71 - $51.62 per hour. The final salary will be set based on internal equity, experience, education, and other factors; this pay scale is not a promise of a specific wage.
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