QA Specialist - Manufacturing Operations (GMP) Onsite | Norwood, MA 1st Shift | Sunday-Wednesday Overview The QA Specialist supports cGMP mRNA drug substance manufacturing by providing real‑time quality oversight and ensuring operations align with a rigorous, globally compliant Quality System. Responsibilities Manufacturing compliance — Applies broad knowledge of GMP manufacturing requirements, quality disposition, and Quality System standards Cross‑functional partnership — Works closely with internal teams to disposition plasmid, drug substance, and drug product Quality initiatives — Contributes to quality‑focused projects across the organization Documentation oversight — Authors and reviews SOPs, policies, and batch production/testing records to ensure cGMP compliance Batch record review — Oversees executed electronic and paper batch records for accuracy and adherence to standards Deviation evaluation — Reviews manufacturing deviations and reinforces GMP, SOPs, and proper clean‑room behaviors Process documentation — Follows procedures for clear, accurate documentation of equipment operation, process instructions, and process data Training and data integrity — Ensures compliance with training requirements and data integrity expectations Issue escalation — Escalates manufacturing, safety, and quality concerns to department leadership Process monitoring — Monitors operations to verify compliance with specifications and quality criteria Safety adherence — Practices safe work habits and follows established safety procedures Operational efficiency — Applies technical knowledge to enhance manufacturing efficiency On‑floor oversight — Provides real‑time quality support through observation of manufacturing activities Raw material review — Reviews and releases raw materials; supports streamlined rejection and destruction processes Deviation reporting — Identifies, classifies, and reports deviations appropriately Startup documentation — Develops batch records, SOPs, and training materials for startup and ongoing operations Internal audits — Participates in internal audits to assess compliance with SOPs, GMPs, and regulatory requirements Regulatory understanding — Demonstrates foundational knowledge of health authority regulations and their internal application Project leadership — Leads cross‑functional projects end‑to‑end and contributes to continuous improvement initiatives SME support — Serves as a subject matter expert and resource for new hires Problem solving — Troubleshoots complex issues and drives effective corrective actions Qualifications Bachelor's degree or equivalent experience 2-5 years of experience in biotechnology, biopharmaceuticals, or other regulated industries; QA or training/document control experience preferred Knowledge of FDA, EU, and ICH guidelines and relevant regulatory expectations Experience with quality systems including batch record review, deviation management, and change control Proficiency in authoring and reviewing GMP documentation Familiarity with environmental monitoring and microbiological testing