Senior Quality Auditor - Hybrid/Remote

REQUIRED QUALIFICATIONS: 

Knowledge of:

• Advanced applied knowledge of auditing principles and practices in an FDA regulated industry such as biologics, blood, tissues, pharmaceutical or medical device.
• Knowledge of Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP) required.
• Knowledge of contract manufacturing principles and practices desired.

Ability to:

• Think analytically and critically; communicate and collaborate effectively with internal stakeholders and with external partners and clients.
• Demonstrate strong technical writing skills.
• Meet deadlines and manage multiple tasks and projects simultaneously; ability to actively engage in strategic planning regarding audit process.
• Demonstrate proficiency with Microsoft Office applications; strong interpersonal skills; and work independently and as part of a team.
• 50-70% travel required

Education and/or Experience:

• Bachelor’s degree in medical technology, biology, biotechnology or other health-science related field. However, upon evaluation, equivalent related experience and/or education may be substituted for the degree requirement. Auditor certification required.
• Eight years of experience as an auditor in an FDA-regulated industry such as biologics, blood, tissues, pharmaceutical or medical device.

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

• Auditor certification desired (ASQ, RAC, etc.)
• Experience or knowledge of Good Tissue Practices (GTP), Good Laboratory Practices (GLP), Good Distribution Practices (GDP), and/or Good Clinical Practices (GCP)

Proof of COVID-19 vaccination with acceptable documentation is required for employment. NMDP will consider all requests for medical or religious accommodation.