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Day - 08 Hour (United States of America)This is a Stanford Blood Center job.
A Brief Overview
Under the general supervision of the Technical Services Director, perform the quality assurance duties of the Technical Services department by writing/revising department equipment and process validation plans, managing equipment preventative maintenance program, manage training records, perform process and computer audits, write/revise procedures for regulatory compliance as necessary. Prepare training binders for new staff and monitor new and incumbent staff training is up to date. Ensure annual SOP and label review performed, review departmental records, help determine corrective actions for events by performing root cause analysis, and is involved in process improvement. Perform post-donation information follow-up that affects safety, purity, and quality of the product by quarantine/discard of units, notification of customers and tracking of recalls. Provide notification to hospitals, regulatory agencies and other customers of test results that affect patients/general population safety.
Locations
Stanford Blood Center
What you will do
- Write/revise/review equipment, process validation plans, test cases, and procedures, as necessary. Ensure annual review is completed for all departmental procedures (SOPs), forms and labels. Examples: Write new equipment validation plans for new freezers, refrigerators, and repair validations for sealers, etc.
- Prepare training binders and training schedule for new staff. Ensure completion of training documentation including Healthstream and SBC SOPs. Ensure 6 month and annual competency is completed on time. Maintain training documentation files. Perform annual exposure control plan training for Technical Services team members. Perform the Global Manufacturing Practices *GMP) training for all new hires of Technical Services Examples: Prepare new staff training binders and continually monitor new and incumbent staff training records for completion. Maintain training records.
- Review department records for accuracy and ensure they meet acceptance criteria, including state and federal regulatory guidelines and internal policies. Manage equipment preventative maintenance (PM) program. Examples: Review temperature monitoring, equipment, distribution, and QC records. Ensure PM is performed on time and enter new equipment in the quality system software.
- Review/discard/release blood products from quarantine based on review process. Perform hospital/customer/county and state notification of infectious disease exposure. Examples: Complete PDIF, positive test result checklists and perform notifications of various customers as needed.
- Write, revise, review, schedule and perform audits of laboratory and computer processes to verify staff performs tasks per procedure. Examples: Perform weekly deferral, prohibiting factors, critical inventory and process audits; ensure staff follow procedures.
- Perform root cause analysis for events and determine corrective action, monitor trends, and initiate process improvement as needed. Ensure timely completion of event reporting, quality indicators, and corrective action plans as required by regulatory entities. Examples: Look for trends of temperature monitoring system and get compressor cleaned or Freon added as necessary. Generate statistical data for infectious disease markers, quality indicators, and events.
- Act as member of Safety Committee and perform inspections of the department to ensure Health and Safety compliance. Examples: Ensure department compliance with Health and Safety inspections.
- Act as inspection coordinator for the department during internal and external inspections. Examples: Act as department coordinator obtaining records as needed.
- Initiate and route change controls for departmental projects.
- Lead quality assurance meetings in absence of supervisor.
- Monitor and maintain equipment maintenance in DID. Follow up with corresponding subdepartment to ensure maintenance is performed within due date. Monitor, track and trend problem equipment.
- Strictly observe privacy and security related policies, procedures and practices to preserve the integrity and confidentiality of medical and other sensitive information pertaining to donors, patients, research subjects, and employees. Act as a responsible information steward and treats information as sensitive and confidential in accordance with federal and state laws and with professional ethics, accreditation standards and legal requirements. Do not disclose protected health information inappropriately.
- May be required to enter areas where other individuals work with human blood; potential may exist for unanticipated exposure to bloodborne pathogens by splash or spill.
Education Qualifications
- High School Diploma or GED Required
- Associate's Degree Preferred
- Bachelor's Degree Preferred
Experience Qualifications
- 7+ years to 10 years experience in GMP environment with High School diploma Required or
- 5+ years to 7 years experience in GMP environment with Associate's degree Preferred or
- 1+ year to 2 years experience in GMP environment with Bachelor's degree Preferred
Required Knowledge, Skills and Abilities
- Demonstrated ability to train staff.
- Quantitative and qualitative data analysis skills.
- Basic understanding of current Good Manufacturing Practices (cGMP) and application in work setting.
- Demonstrated organizational skills and detail orientation and ability to manage competing priorities.
- Ability to effectively communicate orally and in writing with diverse audiences; ability explain technical concepts clearly and concisely.
- Ability to maintain appropriate current knowledge of and interpret specific government agency requirements (statutes, regulations, licenses, and permits).
- Ability to work independently and with minimal supervision.
Licenses and Certifications
- None .
Physical Demands and Work Conditions
Physical Demands
- Frequent Sitting.
- Occasional Walking.
- Occasional Standing.
- Occasional Bending.
- Occasional Squatting.
- Occasional Kneeling.
- Constant Hand Use.
- Frequent Repetitive Motion Hand Use. Keyboarding
- Occasional Grasping.
- Occasional Pushing and Pulling.
- Occasional Reaching (above shoulder level).
- Frequent lifting of 0 - 10 lbs. 1 to 4 in height
- Occasional lifting of 11 - 20 lbs. 1 to 4 in height
- Occasional lifting of 21 - 30 lbs. 1 to 4 in height
- Seldom lifting of 31 - 40 lbs. 1 to 4 in height
- lifting of 40+ lbs. 0 to 0 in height
- Frequent lifting of 0 - 10 lbs. 1 to 10 in height
- Occasional lifting of 11 - 20 lbs. 1 to 10 in height
- Occasional lifting of 21 - 30 lbs. 1 to 10 in height
- Seldom lifting of 31 - 40 lbs. 1 to 10 in height
- lifting of 40+ lbs. 0 to 0 in height
- Category III - Tasks that involve NO exposure to blood, body fluids or tissues, and Category I tasks that are not a condition of employment
These principles apply to ALL employees:
SHC Commitment to Providing an Exceptional Patient & Family Experience
Stanford Health Care sets a high standard for delivering value and an exceptional experience for our patients and families. Candidates for employment and existing employees must adopt and execute C-I-CARE standards for all of patients, families and towards each other. C-I-CARE is the foundation of Stanford’s patient-experience and represents a framework for patient-centered interactions. Simply put, we do what it takes to enable and empower patients and families to focus on health, healing and recovery.
You will do this by executing against our three experience pillars, from the patient and family’s perspective:
- Know Me: Anticipate my needs and status to deliver effective care
- Show Me the Way: Guide and prompt my actions to arrive at better outcomes and better health
- Coordinate for Me: Own the complexity of my care through coordination
Equal Opportunity Employer Stanford Health Care (SHC) strongly values diversity and is committed to equal opportunity and non-discrimination in all of its policies and practices, including the area of employment. Accordingly, SHC does not discriminate against any person on the basis of race, color, sex, sexual orientation or gender identity and/or expression, religion, age, national or ethnic origin, political beliefs, marital status, medical condition, genetic information, veteran status, or disability, or the perception of any of the above. People of all genders, members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply. Qualified applicants with criminal convictions will be considered after an individualized assessment of the conviction and the job requirements.
Base Pay Scale: Generally starting at $39.71 - $51.62 per hourThe salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training. This pay scale is not a promise of a particular wage.
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What We Do
Stanford Health Care, with multiple facilities throughout the Bay Area, is internationally renowned for leading edge and coordinated care in cancer care, neurosciences, cardiovascular medicine, surgery, organ transplant, medicine specialties, and primary care. Throughout its history, Stanford has been at the forefront of discovery and innovation, as researchers and clinicians work together to improve health, alleviate suffering, and translate medical breakthroughs into better ways to deliver patient care. Stanford Health Care: Healing humanity through science and compassion, one patient at a time.
At Stanford Health Care, your career is supported within a distinctive hospital culture. This environment compliments the pioneering, collaborative atmosphere that has earned us our worldwide reputation for excellence.
