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Quality Assurance Specialist - Cincinnati, United States - Nitto Denko
Description
Equal Opportunity EmployerKey Responsibilities:
Writes SOP's, protocols, validation plans and compliance documents for cGMP program. Acts as departmental resource for cGMP programs. Oversees qualification of instruments, equipment, facility, clean rooms and computer hardware - software. Sets-up and organizes tracking program for equipment used in cGMP work. Reviews and authorizes batch production records and quality control documentation. Performs compliance audits of suppliers, contract labs and vendors then writes audit reports. Performs internal audits and ensures observations are corrected.
Sets-up and tracks material flow and material-labeling process to ensure compliance with cGMP program Trains staff in area of cGMP and maintains training records.
Job Knowledge Required:
BS/BA in science with 1-3 years Quality Assurance cGMP experience or an Associate degree with 5+ years of Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience.
High level of knowledge in cGMP guidelines as specified in ICH Q7A. Knowledgeable in instrument, equipment, facility, clean rooms and software qualification - validation. Experienced at writing qualification and validation plans for facilities, equipment and manufacturing processes. Experienced in auditing suppliers, analytical contract labs and vendors. Knowledge of annual product review and stability study protocols per ICH. Solves complex, non-routine analytical problems. Trains others in area of cGMP. Very strong oral and written communication skills.
