Specialist, Quality Assurance (Second Shift)

Role: Quality Assurance Specialist supporting GMP manufacturing and laboratory operations in biopharmaceuticals, biologics, or vaccines. Responsibilities: independently manage projects ensuring compliance with cGMP, review and support GMP documentation (IQ, OQ, batch records), perform environmental monitoring review, lead shopfloor audits, and assist in deviation investigations and change controls. Requirements: High school diploma, 4+ years in manufacturing, laboratory, or related fields, with at least 2 years in GMP or FDA-regulated environment; experience with aseptic techniques and batch record review preferred. HighValue: 2nd shift (evening), 10% travel, experience in aseptic manufacturing, biological drug substances or products, GMP with biologicals, and familiarity with relevant tools like SAP, Veeva, GLIMS. WorkSetup: onsite with flexible schedule, supporting ongoing manufacturing activities.