What are the responsibilities and job description for the QA and Compliance Manager position at Integrated Resources, Inc ( IRI )?
Role Overview
We are seeking a highly skilled QA Specialist to join our team at Integrated Resources, Inc. (IRI). As a QA Specialist, you will play a critical role in ensuring that our manufacturing site meets internal and regulatory cGMP and CFR requirements. Your primary responsibility will be to 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 Responsibilities
- Provide daily QA support to warehouse, bulk manufacturing and packaging lines, including workorder evaluation
- Perform or support activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Review
- Perform or support activities related to Line Audits, Line or Area Cleaning Verifications
- Participate in the design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's)
- Support site metrics, compliance improvement and training initiatives
- Assist in capturing site metrics and promoting improvement opportunities
- Prepare APR contributions as needed within schedule
- Generate and examine documentation regularly for inconsistencies, gaps or errors
- Support activities related to Destruct Orders and Shipping Orders
- Maintain documents retention schedule and file completed documents to the applicable areas
