Job Description:
- Responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.
- The In-Process Quality Assurance Associate (IPQA) will focus on initial deviation investigative phases related to manufacturing process deviation.
- Facilitates the use of existing management processes regarding deviations, investigations, and preventive actions.
- Performs area assessments and ensures compliance with SOPs, Policies and Procedures.
- Responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place.
- Work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities.
- Administration and management of deviations/investigation in Trackwise.
- Execute the final release inspection of packaging lines.
- Perform acceptance sample analysis for validation and investigation support.
- Responsible for the review and approval of controlled documents.
- Actively communicate with customers to facilitate continuous process improvement.
- Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: FDA etc.)
QUALIFICATIONS:
- Minimum Associate’s degree in scientific discipline or closely related technical field of study is required.
- 1-3 years of pharmaceutical and FDA is preferred.
- Understanding of the production processes used in the Pharmaceutical Industry.
- GMP experience is required.
