San Diego Blood Bank · 3 months ago
Quality Assurance and Compliance Specialist II
San Diego, CA
Full-time
Onsite
Mid Level
$34.28/hr - $34.28/hr
4+ years expSan Diego Blood Bank is a nonprofit organization dedicated to saving and improving lives through blood and biotherapies. The Quality Assurance and Compliance Specialist II will participate in maintaining a Quality Management System, ensuring that the performance and quality of products conform to established standards and regulatory requirements.
Health CareNon Profit
Responsibilities
Prepares audit tools, conduct internal audits, submit audit report and perform follow up on related corrective action plans
Perform regulatory review of standard operating procedures, validations and other regulated documents
Assist in the maintenance and improvement of the San Diego Blood Bank quality and compliance programs
Develop and revise policies, standard operating procedures (SOPs) and other documents
Host and/or assist departments in preparing for external inspections
Participate in regulatory, accreditation and third-party inspections
Assist with focused audits as identified by new process design, problem management, and/or external inspections
Perform follow up on corrective action plans submitted in response to problem management, supplier issues, product complaints, and other issues as directed by management
Assist with the development of quality metrics and key performance indicators for regulated areas of the blood bank
Assist with new/renewal applications for accreditation, licensure, certification, registration and waivers, as well as FDA license amendments
Assist with donor record audit reviews, including relevant investigation and resolution of errors or discrepancies
Assist with recall, market withdrawal, regulatory and consignee notification
Assist with the development of performance improvement initiatives and implementation processes
Participate in corrective and preventive action teams, assist with investigation and root cause analysis and verify that actions are implemented and effective
Initiate Quality Incident Reports after identifying errors and quarantine products as needed
Perform final review of Quality Incident Reports as needed
Assist with the investigation of Quality Incident Reports within the scope of his/her knowledge as needed
Educate staff on laws, regulations and standards that govern the San Diego Blood Bank
Ensure compliance with all applicable state and federal laws and regulations and with the standards of the accrediting/certifying agencies
Participate in appropriate departmental meetings, and attend other meetings as assigned
Represent the San Diego Blood Bank at conferences and meetings as assigned
Enhance professional growth and development through participation in educational programs, current literature review, in-service meetings and workshops
Understands and adheres to the policies and standards as developed as part of the San Diego Blood Bank Compliance Program
Performs other related duties as assigned or requested
Qualification
Required
Bachelor's degree in related field or discipline
ASQ, CPHQ, Health Care Compliance Certification Board (CHC, CHRC), or similar certification required or must be obtained within two (2) years of hire
Minimum of four (4) years of experience working in a Quality Assurance or Regulatory Affairs department. Experience should include participation in FDA and State site inspections, experience with GMP requirements, application of quality assurance principles, and healthcare compliance
Must have ability to move around office and stand for prolonged periods
Must be able to work on computer 4 – 8 hours a day
Must have ability to travel to mobile or fixed collection sites and to off-site meetings
Ability to perform tasks per GMP regulations including following detailed SOPs, maintaining training, deviation reporting and good documentation practices
Ability to perform accurate detail-oriented work
Ability to organize activities effectively, use effective problem-solving techniques and make sound decisions
Ability to communicate effectively with internal and external customers
Must be able to establish priorities and multi-task
Ability to work well with others
Must possess good verbal and written communication skills and teaching abilities
Must have good knowledge of standards and regulations that apply to blood banking, umbilical cord banking, cellular therapy services, clinical laboratory, and clinical research
Proficient in Microsoft Suite applications (Excel, Word, PowerPoint)
Preferred
Advanced degree preferred
Experience in a blood bank setting preferred
Additional Experience in cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred
Benefits
Employees working 30 or more hours per week are eligible for employer sponsored health benefits (Medical, Dental, & Vision plans)
Earn up to 120 hours of paid vacation in your first year.
7 paid Holidays + 1 personal holiday provided annually.
40 hours of paid sick time provided annually.
403b retirement plan with 3% employer match starting on your first day.
Employee Assistance Program - Free for employees and their families
Service Awards and recognition.
Company
San Diego Blood Bank
San Diego Blood Bank is a non-profit that provides blood and blood-related lab services to some 50 hospitals in Southern California. It is a sub-organization of San Diego Blood Bank.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Doug Morton
Chief Executive Officer
Helen Bixenman
Chief Quality, Regulatory Affairs and Risk Officer, Chief Compliance/Privacy Officer
Recent News
2025-04-08
Company data provided by crunchbase