Quality Assurance and Compliance Specialist II

Position Title:Quality Assurance and Compliance Specialist II

Salary:$34.28 per hour

Schedule:Monday – Friday; 8:00am to 5:00pm

Are you passionate about making a real difference in your community? Are you looking for a job where you can contribute to a meaningful cause and grow professionally? If so, San Diego Blood Bank invites you to join our dynamic & diverse team dedicated to the mission of saving & improving lives through blood and biotherapies.

WHY CHOOSE SDBB?
At San Diego Blood Bank, we provide Southern California regional hospitals with a wide of blood banking services. These include blood collection, component preparation, plateletpheresis, plasmapheresis, leukapheresis, washed blood, frozen blood, autologous storage, designated services, and a reference laboratory. San Diego Blood Bank’s Cord Blood Banking Program provides lifesaving stem cell transplants to patients worldwide.

Founded in 1950, San Diego Blood Bank has been an important institution in the San Diego community for decades. Today, SDBB is continuing to grow to meet the changing needs of our healthcare community.

San Diego Blood Bank is a 501(c)(3) nonprofit organization also operating as Southern California Blood Bank. We serve hospitals in San Diego, Los Angeles and Orange Counties. We are the primary blood provider to Rady Children’s Hospital-San Diego and the safety net for hospitals in our region. Every year, more than 150,000 units of blood provided by San Diego Blood Bank are transfused into patients of all ages, socio-economic and ethnic backgrounds throughout Southern California.

These patients are struggling with life-threatening medical conditions including cancer and other blood disorders, severe burns, organ transplants, emergency surgery, trauma, childbirth complications and more.

Under the direction of the Manager, Quality & Regulatory Affairs, the Quality Assurance and Compliance Specialist II participates in maintaining a Quality Management System that supports the manufacture of FDA-regulated biologic blood, cell and tissue products and other related regulatory activities. The Specialist ensures that performance and quality of products conform to established standards and regulatory requirements.

• 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…