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Quality Assurance Product Release Coordinator
2 months ago
Requisition ID: 32331
At Terumo Blood and Cell Technologies, our 7,000+ global associates take pride in their work, understanding that our contributions significantly affect the lives of patients worldwide.
We specialize in developing medical devices and related products that facilitate the collection, separation, manufacturing, and processing of various blood and cell components. Through our innovative technologies and service offerings, we positively impact patients' lives every second of every day, and we are dedicated to expanding the number of patients we assist.
With a team comprised of some of the industry's brightest minds, an unparalleled global presence, comprehensive benefits, and a unique culture, Terumo Blood and Cell Technologies offers an excellent environment for professional growth and collaboration focused on making a meaningful difference.
JOB TITLE: Quality Product Release Specialist
JOB SUMMARY
Operating with minimal oversight, this role involves reviewing and approving Device History Records (DHRs) and other documentation for finished products and equipment to ensure compliance with established regulatory and quality standards before they are released for sale. The position also entails reviewing, approving, and coordinating special release scenarios such as Quality Control Holds, Controlled Distribution, and management of Distribution SAP transactions when applicable.
ESSENTIAL DUTIES
- Independently coordinate and gather all necessary documentation for a complete DHR.
- Ensure timely and accurate approval of product release documentation and SAP release transactions.
- Manage Controlled Distribution, Control of Distribution, and Quality Control Holds.
- Enhance internal processes to improve efficiency and ensure product quality for external clients.
- Interpret, implement, and suggest modifications to operating policies, Standard Operating Procedures (SOPs), and Work Instructions (WINs) as necessary.
- Assist in fulfilling customer requests for established product certificates (Certificates of Compliance).
- Maintain and update all product release indices as required.
- Support international facilities in adhering to Quality System and regulatory standards.
- Keep regulatory records in accordance with retention requirements.
- Participate in internal and external quality audits related to release documentation, SAP transactions, and Policies/SOPs/WINS.
- Balance and prioritize daily tasks with ongoing continuous improvement initiatives within the Release Coordinator scope.
MINIMUM QUALIFICATION REQUIREMENTS
Education
A Bachelor's degree or an equivalent combination of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
- A minimum of 2 years of relevant experience.
- Experience in a manufacturing setting is required.
Skills
- Proficiency in relevant PC software applications and the ability to use them effectively.
- Strong verbal and written communication skills.
- Ability to routinely identify problems and propose solutions through teamwork, failure mode analysis, and other analytical methods.
- Contribute to the development of solutions for moderately complex issues.
- Knowledge of manufacturing protocols, statistical tools and methodologies, continuous improvement techniques, and basic project management skills.
-Or-
An equivalent competency level acquired through a combination of these qualifications may be considered.
PHYSICAL REQUIREMENTS
Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting of 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 functions.
Target Pay Range: $34.00 to $ Hourly pay rate will be determined based on 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 offer competitive total reward packages that include compensation, benefits, recognition, and a variety of well-being, work-life, and recognition programs designed to support you and your family. Our extensive benefits offerings include multiple group medical, dental, and vision plans, a robust wellness program, life insurance, and disability coverage, along with various voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance, and more. To assist with retirement savings, we provide a 401(k) plan with a matching contribution, and for work-life balance, we offer vacation and sick time programs for associates. Our focus is on safeguarding the personal welfare of our associates and their families, helping them achieve personal goals, and providing 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 guide our direction, actions, and commitment to our corporate mission of contributing to society through healthcare: Respect, Integrity, Care, Quality, and Creativity. We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.