Hiring: Quality Assurance Specialist (QAS) I Company: SOFIE Location: Sterling, VA Job Posted Time: 2026-09-17 09:35:57 Target Skills & Keywords : Microsoft Office, Quality Assurance, Regulatory Compliance About the job Experience: •1-2 years of QA, Pharmacy, and/or CGMP manufacturing experience •2 years of QA, Pharmacy, and/or CGMP manufacturing experience Required Skills: •Job Description | Quality Assurance Specialist (QAS) I •Title | Quality Assurance Specialist I •Reports To | Regional Manager, Quality Assurance (or equivalent QA Manager) •The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level. •Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations. •Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance. •Strong collaboration, including problem solving and continuous improvement efforts, and communication with the Facility Manager and Operations team. •Write, review, approve, and implement procedures, specifications, processes, and methods as required. Qualifications: •Bachelor’s Degree (Scientific / Medical / Quality), at minimum, preferred. •Quality, Pharmacy, or CGMP manufacturing experience preferred. •Knowledge of USP, FDA, and cGMP regulations preferred. •Knowledge of how and ability to write, review, and revise SOPs required. •Demonstrated capacity to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required. •Demonstrated capacity to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. •Demonstrated capacity to write reports, business correspondence, and procedure manuals required. •Demonstrated capacity to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required. •Demonstrated capacity to define problems, collect data, establish facts, and draw valid conclusions required. •Demonstrated capacity to solve problems and handle issues required. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!