Development Quality Assurance Associate in Durham, NC at Integrated Resources, Inc

Date Posted: 1/11/2020

Job Snapshot

Job Description

This position will be responsible for all controlled documents at R&D. This positions will be responsible for reviewing/approving all Development batch records and associated documentation. This position will be responsible for developing and optimizing current cGMP document systems. They will 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

  • BS degree in Science preferred
  • Must have experience with cGMP
  • Attention to detail
  • Strong computer skills
  • 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)