QA Specialist V

Software Guidance & Assistance, Inc., (SGA), is searching for an QA Specialist V for a CONTRACT assignment with one of our premier BioTech clients in Morrisville, NC.

This position will assist with QA activities at the firm to ensure compliance with CLIA, CAP and FDA regulations and requirements

Responsibilities :

• Responsible for maintaining, updating and versioning of policies and protocols.
• Ensure that record keeping under FDA/GLP requirements are attributable, legible, contemporaneous, original and above all, accurate.
• Review IT change control documents including risk analysis, IQ, OQ, URS and other software validation documents.
• Provide constructive feedback on validation plans to software development teams.
• Demonstrate strong proficiency in the application of the Corrective and Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources
• Manage employee training files
• Assist in development and management of the firm's quality management system.

Required Skills:

• Must have strong regulatory compliance knowledge including GLP and Google Cloud Platform
• Must have experience writing and/or reviewing clinical software validation documents
• Able to assist with external audits of vendors and subcontractors
• Must be detail oriented with excellent prioritization and organizational skills
• Superior analytical and problem solving skills
• Must be able to deliver results on schedule in a fast-paced, dynamic environment

Preferred Skills:

• Experience in the clinical or diagnostics industry strongly desired
• Experience working in an environment where custom and COTS (customized of the shelf) software needs to be validated

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy