Responsibilities:

• Responsible for reviewing/approving all Development batch records and associated documentation.
• Responsible for developing and optimizing current cGMP document systems.
• Oversee the training records for the R&D team.
• Assist in preparing company quality metrics as well as any document related tasks as they are necessary.
• Responsible for reviewing and maintaining the Company SOPs, training, specifications, investigations, deviations and CAPA systems in an orderly and secure manner
• Assure all SOPs and Controlled Documents are in “current” status
• Review and approve all Developmental Batch Records and all associated documentation
• Aiding in reviewing/approving equipment qualification documentation and internal calibrations
• Issuance and Recollection of controlled documentation
• Aiding in training activities
• Perform additional duties as required
• Assisting with Government Agency Inspections

Requirements:

• BS degree in Science preferred
• Must have experience with cGMP
• Preferred experience with Formulation Dev and Analytical testing
• Preferred experience with Empower 3 software review
• Previous job experience
• Minimum 2 -3 years working in a Pharmaceutical cGMP environment
• Knowledge of Microsoft Office Systems
• Pharmaceutical Background (Generics preferred, but not mandatory)