Documentation Specialist I

Duration Contract until December 2026 with possibility to extend. Education and Experience High school diploma and at least 5 years of experience. A.A. degree and at least 3 years of experience. Bachelor's degree and at least 1 year of experience (final batch review). Requirements Experience with CAPA, batch review, technical writing, and documentation systems for locating errors and change action requirements. Experience with quality systems, technical writers, CAPA, ERP, and documenting systems or similar for tech writers. Experience in pharmaceutical or biotech industry. Responsibilities Track and review manufacturing batch records to ensure compliance with regulatory requirements. Follow up with manufacturing technicians to ensure corrections are completed promptly. Maintain error tracking metrics to address and correct repeated violations of GDP. Coach shop‑floor technicians on GDP as applicable. Identify and Escalate GDP issues that could affect the safety, efficacy, and quality of drug substance. Review batch record structure and recommend simplifications to minimize errors. Ensure batch record review cycle time. Participate in deviation investigations and CAPA creation. Must be detail oriented, work quickly with high accuracy, possess sound interpersonal and information gathering skills, and work effectively in a team environment. Years of experience: 0–3 years. Shift 1st Shift. #J-18808-Ljbffr