What are the responsibilities and job description for the Quality Specialist position at Integrated Resources, Inc ( IRI )?
Primary Activities :
- Fully trained in relevant Standard Operating Procedures (SOPs), Work Instructions (WIs) and competency-based activities
- Learns cGMPs, the manufacturing process, and our company quality systems, including SAP, GLIMS and electronic logbook, laboratory data, and batch record platforms
- Provides presence on the shop floor to support compliance and data integrity.
- Reviews production documentation such as batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors
- Reviews and approves new and updated SOPs and Controlled Job Aids
- Actively participates in the Tier process and uses this forum to make concerns visible and to partner with the functional area on resolution
- Fosters a customer service attitude within the functional area
Quals
Required Education :
Required Experience and Skills :
