San Diego Blood Bank
  • 09-Jan-2018 to 10-Mar-2018 (PST)
  • Quality Assurance & Compliance
  • San Diego, CA, USA
  • DOE
  • Salary
  • Full Time

Medical, Dental, Vision, 403(b), Retirement and more!


Quality Assurance and Compliance Specialist III 

 

The Quality Assurance and Compliance Specialist III (QA Specialist) will assist the VP, Quality and Regulatory Affairs with developing, implementing and executing quality assurance processes and practices that support the manufacture of FDA-regulated biologic blood, cell and tissue products and other related regulatory activities. Assist in managing and monitoring systems and processes, in support of the SDBB Quality Plan, promoting an organizational culture of excellence. Ensure that performance and quality of products conform to established standards and regulatory requirements. Requires the ability to analyze complex issues, work independently and the flexibility to meet changing business and stakeholder needs.

QA Specialist Education, Licenses & Certifications:

  • Bachelor's degree in medical technology or other health science-related field required.
  • Advanced degree preferred.
  • Licensed RN or CLS and/or SBB(ASCP), ASQ or Health Care Compliance Certification Board (CHC, CHRC) certification required.

QA Specialist Experience:

  • Minimum 5 years of blood bank quality and regulatory affairs experience required. Experience should include participation in FDA site inspections, experience with GMP requirements and application of quality assurance principles.
  • Additional experience in cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred.

QA Specialist should possess the following Knowledge, Skills, Abilities:

  • Knowledge of operational characteristics, services and activities of a quality program  and in principles and practices used in healthcare/laboratory management, governmental compliance, internal audits, risk management, or regulatory affairs. 
  • Ability to approach challenges with confidence.
  • Strong problem solving techniques and ability to make sound decisions.
  • Ability to perform accurate detail oriented work.
  • Effective communicator, both internally and externally. 
  • QA Specialist must be able to multi-task and establish priorities.
  • Ability to use computer systems and document management software. 
  • Must work well with others and possess effective teaching abilities. 
  • Good knowledge of standards and regulations that apply to blood banking. 
  • Spreadsheet and Access programming helpful.
  • QA Specialist must have a high degree of integrity, be facilitative rather than confrontational in nature, understand the importance of compliance and be an advocate of quality services.

 

The San Diego Blood Bank is an Equal Opportunity Employer.

EOE/Minority/Female/Disability/Vets

San Diego Blood Bank
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