What are the responsibilities and job description for the Regulatory Affairs and Quality Specialist position at Integrated Resources, Inc ( IRI )?
About the Job
The QA Specialist position at Integrated Resources, Inc. (IRI) offers an exciting opportunity for a highly motivated and detail-oriented individual to join our team. As a QA Specialist, you will be responsible for ensuring that our manufacturing site meets internal and regulatory cGMP and CFR requirements. You will provide daily Quality Assurance support to various departments, including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance, and others related to site Quality Assurance responsibilities.
Main Accountabilities
- Deliver daily QA support to warehouse, bulk manufacturing and packaging lines, including workorder evaluation
- Conduct or support activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Review
- Conduct or support activities related to Line Audits, Line or Area Cleaning Verifications
- Participate in the development of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's)
- Collaborate with teams to enhance site metrics, compliance improvement and training initiatives
- Assist in collecting site metrics and driving improvement opportunities
- Prepare APR contributions as needed within schedule
- Regularly review and verify documentation for consistency, completeness, and accuracy
- Support activities related to Destruct Orders and Shipping Orders
- Maintain accurate records of documents retention schedule and filing of completed documents
