Quality Assurance Specialist

Onsite in Frederick MD

12 month contract

On the floor Manufacturing QA

3rd shift ideally - first and second shift potentially after a few months, but not guaranteed

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist. In this role you will support the activities of the Quality Assurance department at the Frederick, MD manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and quality objectives.

Shift is Wed-Sat 5:00 pm- 3:30 am 10 hours / day x 4 days / week

Responsibilities (included but not limited to):

• Provide QA support on the floor for production
• Ensure process control measures are in place and followed in product manufacturing
• Receipt and disposition of incoming apheresis material.
• Oversee and authorize shipment of final product
• Verify and ensure timely issuance of production documents and labels
• Review batch-related documentation and ensure resolution of issues to release and ship product.
• Gather and report metrics to measure performance
• Identify continuous improvement actions
• Ensure timely resolution and escalation of issues
• Ensure all product-related Deviations are initiated, investigated and resolved.
• Ensure that associated CAPAs are initiated and resolved, as needed.
• Perform lot closure activities.
• Ensure approval and timely delivery of final product.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.

by Jobble