Title: Sr. Quality Release Technician
Location: Asheville, NC
Shift: 2nd shift – 3:30 – 1:00am
Description: Position Summary:
Under the direction of the Manager, Operations Quality, the Sr. Quality Release Technician is responsible for the release of finished product placed on electronic hold.
Responsibilities
Verify electronic transactions for consistency and accuracy with paper documents.
Ensure that NCM (non-conforming material) information is updated.
Place processing certifications in DHR (lot file/batch record).
Supply the quantity for the lot and keep a running balance in the DHR (lot file/batch record) file.
Perform final review of the DHR (lot file/batch record), including reconciliation of records, confirmation of that any NCM has been closed, and file close-out.
Investigation and problem-solving of any discrepancies with Manufacturing and Warehouse departments.
Research, verification, and reconciliation of product from sterilization vendors and third-party distributors.
Verification and certification of the information entered into SAP before product release.
Identify improvement opportunities and ensure workflow is optimized to minimize the amount of time the product is on Quality Hold.
Escalate issues to Quality Manager.
Minimum Requirements
Qualifications:
Minimum of a high school diploma or GEDProficiency in SAP QM system is preferred
Certification by ASQ is a plusMust have prior job experience in a quality position and a good understanding of lot file documentation and good documentation practice
Must be able to read, write, and understand the English language.
Must be able to perform simple math such as add, subtract whole numbers. Experience with GMP/ISO procedures.
Professional Characteristics:
Successful under a high level of scrutiny and accountability
Strong Communication Skills
Must be able to work well with others in a team environment.
Able to adjust to changing operating conditions quickly and efficiently and very pace as required.