Quality Management Specialist (52712)

GAP SOLUTIONS INC • Bethesda, MD

13d • $75,000 - $105,000 • Onsite

About The Position

Provide services as a Quality Management Specialist in support of the overall functions of the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID). Serve as a Quality Management Specialist providing independent quality oversight for the implementation, validation, maintenance, and retirement of GxP regulated computerized systems. Apply thorough knowledge of GxP regulations, including Computer Software Assurance (CSA) and Computer System Validation (CSV), to guide teams in meeting compliance expectations. Recommend and collaborate on solution approaches, working both autonomously and with cross functional stakeholders to ensure systems meet regulatory and quality standards.

Requirements

• BA or BS degree required
• 3 or more years of quality assurance experience required
• 3+ years of experience working in a GxP IT environment or GxP Quality Assurance
• Experience with quality standards and regulatory requirements including but not limited to GAMP5, Computer Software Assurance, 21 CFR Part 11, and ICH E6 (R2)
• Direct experience with supporting IT Projects such as GxP Systems
• Experience supporting testing including test incident management
• Experience with writing SOPs and/or reviewing validation plans, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ)
• Experience providing training to cross-functional teams and key stakeholders
• Ability to obtain Public Trust clearance
• Possession of excellent planning, organizational, and computer skills
• Possession of excellent oral and written communication skills

Nice To Haves

• Direct experience with electronic test execution software is preferred
• Experience performing vendor assessments and internal audits is nice-to-have
• Experience performing GxP impact assessments, system risk assessments, validation assessments, and 21 CFR Part 11 assessments preferred
• Experience with Computer Software Assurance preferred
• Certified Quality Auditor, Quality Engineer, ISO Lead, or a related Quality Associated Certification preferred

Responsibilities

• Serve as a Quality Management Specialist providing independent quality oversight for the implementation, validation, maintenance, and retirement of GxP regulated computerized systems.
• Apply thorough knowledge of GxP regulations, including Computer Software Assurance (CSA) and Computer System Validation (CSV), to guide teams in meeting compliance expectations.
• Recommend and collaborate on solution approaches, working both autonomously and with cross functional stakeholders to ensure systems meet regulatory and quality standards.
• Supporting testing including test incident management
• Writing SOPs and/or reviewing validation plans, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ)
• Providing training to cross-functional teams and key stakeholders

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level