Quality Product Release Specialist

3 months ago

Lakewood, United States Terumo BCT Full time

Requisition ID:  32331

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

JOB TITLE: Quality Product Release Specialist

JOB SUMMARY

Working under minimal supervision, reviews and approves DHRs (Device History Records) and other records for finished disposables and equipment devices to ensure they meet established regulatory and quality guidelines prior to release for sale. Release Coordinators also review, approve, and coordinate special release scenarios such as QC Holds, Controlled Distribution, and Control of Distribution SAP transactions, where appropriate.

ESSENTIAL DUTIES

Working independently to coordinate and obtain all required documentation for a complete DHR. Provides accurate and timely turnaround time for approval on product release documentation and SAP release transactions. Responsible for Controlled Distribution, Control of Distribution and Quality Control Holds. Supports internal efforts to improve timeliness and ensure product quality to external customers. Interprets, executes, and recommends modifications to operating policies, SOPs, and WINs, where appropriate. Supports customer requests for established product certificates (Certificates of Compliance). Updates and maintains all product release indices, where appropriate. Supports non-US based facilities in meeting Quality System and regulatory requirements. Maintains regulatory required records per record retention requirements. Involvement in internal and external quality audits regarding Release paperwork, SAP transactions, and Policies/SOPs/WINS. Balance and prioritize essential daily tasks with longer term continuous improvement projects within the Release Coordinator scope.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Experience

Minimum 2 years experience. Requires experience in a manufacturing environment.

Skills

Knowledge and use of relevant PC software applications and skills to use them effectively. Demonstrated ability to communicate effectively both verbally and in writing. Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques. Develops or participates in the development of solutions to problems of moderate to intermediate complexity. Demonstrated knowledge of manufacturing protocols, statistical tools and methodology, continuous improvement techniques, and basic project management skills

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range: $34.00 to $42.00 - Hourly pay rate to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base: 7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare. Respect – Appreciative of others Integrity – Guided by our mission Care – Empathetic to patients Quality – Committed to excellence Creativity – Striving for innovation We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

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