Responsibilities:

• Writes SOPs, protocols, validation plans and compliance documents for c GMP program.
  
• Sets-up and oversees c GMP program for manufacture of Active Pharmaceutical Ingredients.
  
• Acts as departmental resource for c GMP programs.
  
• Oversees qualification of instruments, equipment, facility, clean rooms and computer hardware - software.
  
• Interfaces with prospective clients on c GMP audits then responds in writing to findings.
  
• Interfaces with FDA during audits.
  
• Sets-up and organizes tracking program for equipment used in c GMP work.
  
• Reviews and authorizes batch production records and quality control documentation.
  
• Solves complex, non-routine analytical and product problems independently.
  
• 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.
  

Requirements:

• 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.