Equal Opportunity Employer

Key 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.