QO Clean Room Technician I

Job description

Description Quality Operations Clean Room Technicians Tier I are to monitor filling operations in compliance with company policies and Standard Operating Procedures, as well as FDA and cGMP regulations. Qualified individuals will be responsible to ensure the accuracy and completeness of batch records, and perform personnel monitoring, general operations filling in manual hoods, and other duties as necessary. Technicians will assist with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: · Monitors aseptic techniques of personnel within the clean room. · Monitor Outsourcing filling operations within the clean rooms. · Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed. · Maintains quality assurance documentation. · Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records. · Promotes teamwork both within the QA Team and other departments. · Monitors all filling areas and personnel for adherence to all cGMP, SOP’s and safety regulations. · Keep line and work station clean and orderly to ensure no product line contamination....