Sr. Quality Release Technician

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position: Sr. Quality Release Technician



Location: Asheville, NC 28804



Duration: 12 Months



Job Type: Temporary Assignment



Work Type: Onsite



Shift: Monday to Thursday from 03:30 PM to 01:00 AM

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. The role involves reviewing and reconciling lot file documentation, verifying electronic transactions and SAP information, addressing discrepancies, and supporting the timely release of finished products while maintaining quality and documentation requirements.

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 that any NCM has been closed, and file close-out.
• Investigate and problem-solve any discrepancies with Manufacturing and Warehouse departments.
• Research, verify, and reconcile product from sterilization vendors and third-party distributors.
• Verify and certify 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.

Required Skills:

• Minimum of a high school diploma or GED.
• Proficiency in SAP QM system is preferred.
• Certification by ASQ is a plus.
• Prior job experience in a quality position.
• Good understanding of lot file documentation and good documentation practice.
• Experience with GMP/ISO procedures.
• Must be able to read, write, and understand the English language.
• Must be able to perform simple math such as add, subtract whole numbers.
• 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.

TekWissen Group is an equal opportunity employer supporting workforce diversity.