Sr. Quality Release Technician

TekWissen LLC

Asheville, NC
1 day ago

Highlights

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. 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.

Numbers & Facts

Location	Asheville, NC
Industry	Computer/IT Services
Salary	$20
Company Size	100 to 499 employees
Year Founded	2009
Website	http://www.tekwissen.com/

Description

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.

About Company

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.