Quality Assurance Specialist

Responsibilities: The firm is seeking a Quality Assurance Specialist. This position will assist with QA activities at the firm to ensure compliance with CLIA, CAP and FDA regulations and requirements. 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: Bachelor's degree with at least 5 years of experience in the pharmaceutical, biotechnology, medical device, or diagnostic industries, at least 2 of which should include direct QA experience. Must have strong regulatory compliance knowledge including GLP and GCP 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 https://sgainc.com/. 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 EEO page to request an accommodation or assistance regarding our policy. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Software Guidance & Assistance, Inc. (SGA, Inc.) by 2x Get notified about new Quality Assurance Specialist jobs in Boston, MA. Boston, MA $75,000.00-$95,000.00 1 month ago QA Tester For Free To Play Casual Mobile Game Boston, MA $85,000.00-$95,000.00 2 weeks ago Post Closing/HMDA Quality Assurance Specialist - Hybrid Eligible Cambridge, MA $132,000.00-$165,000.00 3 days ago Burlington, MA $132,000.00-$165,000.00 2 days ago Payment Integrity: Reimbursement Policy Quality Assurance (QA) Analyst Marlborough, MA $130,000.00-$155,000.00 2 weeks ago Associate Director/Director, Quality Assurance Operations Senior Manager/Associate Director, CMC Quality Assurance Quality Control Aerospace Manufacturing (Multiple shifts) Quality Assurance Contact Center Specialist Quality Assurance Specialist, Cellular Therapy We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.