Quality Assurance Specialist

Nov 30, 2022

Avecia: Cincinnati, OH, Ohio, US

Regular Full Time

Equal Opportunity Employer

Key Responsibilities: 

 

 

  • Acts as departmental resource for cGMP programs
  • Writes SOP’s compliance documents for cGMP program.
  • 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.