Responsibilities may include:
- Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)
- Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
- Works in accordance with area Supervision to provide Quality Assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, and product distribution as applicable
- Supports department supervision in oversight and prioritization of day-to-day responsibilities.
- Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
- Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
- Provides an established technical expertise for current processes and oversees training of department personnel on new processes
- Maintenance of retained sample storage
- Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products
- Evaluation of batches / product for compliance with defined specifications
- Sampling, inspection, and control of commercial product labels
- Review and approval of shipping documentation for commercial products
- Other duties as assigned