Quality Assurance Specialist
4 weeks ago
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.
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