Military Spouse Connection Jobs

Chemist II

Date: Jun 11, 2024

Req ID: 3394

Location:

Elkton, MD, US

Company: Terumo Medical Corporation

Department: QM Laboratory Ops

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

The Chemist II independently develops, qualifies, implements, and performs a variety of analytical techniques in accordance with all applicable regulations, quality procedures and safety requirements supporting manufacturing, laboratory operations and development initiatives. The position collaborates with cross functional groups to investigate laboratory and manufacturing issues and implement corrections and improvements that directly effects product safety, quality, and operational efficiency.

Job Details/Responsibilities

• Comply with all safety requirements and regulations.

• Performs detailed technical and quality review and approval of lab results and reports.

• Assists to qualify (IQ, OQ, PQ) and helps maintains analytical laboratory equipment to support project initiatives.

• Develops and qualifies test methods from scientific principles to evaluate product/components.

• Author, review and/or approve laboratory reports, test methods, and standard operating procedures (SOPs).

• Independently develops, implements, and executes test methods is accordance with all applicable regulations and that quality records are maintained. (FDA, ISO, OSHA, etc.)

• Performs analytical measurements and experiments to qualify or resolve product and process issues.

• Supports the creation of specifications relative to area of expertise to ensure product safety and quality.

• Supports routine 5S methodology in laboratory to always maintain constant state of compliance and inspection readiness.

• Maintain current knowledge of analytical testing techniques and equipment.

• Help perform maintenance and calibrations on laboratory and chemical equipment supporting manufacturing operations.

Job Responsibilities (continued)

• Maintains close interactions with cross-functional groups as needed to support required project work and daily manufacturing operations.

• Continually assess test methods and equipment to maintain state of the art technologies.

• Provide support for lab quality activities including laboratory out of specification investigations, CAPAs within agreed upon timelines.

• Interacts with FDA, notified bodies and other regulatory agencies, as necessary.

• Provide analytical technical support to manufacturing operations including routine raw material and product testing, troubleshooting and root cause investigations.

• Train other technicians and manufacturing operators on analytical test methods and use of equipment to ensure competency.

• Perform other duties as assigned.

Knowledge, Skills and Abilities (KSA)

• Demonstrated ability to assess issues, develop and execute solutions with urgency.

• Ability to work independently and with cross-functional teams.

• Demonstrated ability to build organizational relationships and interact effectively across all levels of the organization.

• Extensive knowledge in a variety of analytical techniques and laboratory/mixing equipment

• Strong knowledge of chemical safety

• Demonstrated skill in qualification of testing equipment, and the development and qualification of test methods from scientific methodologies.

• Knowledge of quality system regulations in the areas of chemical testing, laboratory investigations and CAPA.

• Strong interpersonal, verbal, training, and presentation skills.

• Organization skills to ensure management of time for project work and supporting daily activities.

• Proficiency in Microsoft Excel, Word, PowerPoint, and Outlook. MS Project a plus

Qualifications/ Background Experiences

• Requires a four-year degree in chemistry or related scientific discipline or equivalent combination of equivalent relevant education/experience.

• Minimum of 3 years’ laboratory experience in a regulated industry such as medical device/pharmaceutical

• OSHA HAZWOPER or HAZMAT Certification a plus

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.