Senior Supplier Quality Specialist - Remote

REQUIRED QUALIFICATIONS:

Knowledge of:

• FDA GMP regulations and guidance documents (21 CFR 211, 21 CFR 820)
• Strong knowledge of laboratory and apheresis center processes
• Excellent analytical, problem-solving, and communication skills
• Proficiency in using quality management software and tools.

Ability to:

• Communicate professionally and effectively across multiple internal and external audiences.
• Evaluate business needs and develop appropriate solutions in an unconventional environment.
• Adapt quickly to changing environment.

Education and/or Experience:

• Bachelor’s degree in medical technology or other health science-related field. On evaluation, three years in a quality assurance role, in addition to the minimum experience required, may be substituted for the degree requirement.
• Five or more years of experience in a position which required the application of quality systems within a regulated medical industry preferred. Experience should also include at least one-year experience working with Good Manufacturing Practice (GMP) requirements and with the application of quality management principles.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration) 

• Supplier Quality experience in a regulated environment
• Knowledge of FDA Good Tissue Practices
• Experience in/familiarity with high-complexity CLIA/CAP environments (ASCP or equivalent certification desirable)
• Previous laboratory experience in any of the following areas:
  • Histocompatibility
  • Microbiology
  • Diagnostic Immunology
  • Immunohematology
  • Parasitology
  • Cropreservation
• Experience/knowledge of stem cell transplant, cell, and gene therapy and/or biopharmaceutical industry
• Experience/knowledge of United States Pharmacopoeia (USP) Reference Standards 
• Experience with international pharmaceutical regulations strongly preferred.

DEI COMMITMENT:

As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us. 

NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information