Specialist, Quality Assurance- SII

Job Location(s) US-MD-Baltimore

of Openings

Job ID

2024-3782

Category

Sysmex Inostics

Travel

None

Overview

Find a Better Way...

to use your skills and experience.

This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology and improve lives with your innovative ideas and ambitious dreams.

Find a better way : the Sysmex Way.

to improve the lives of others.

Headquartered in Kobe, Japan, Sysmex Corp. is renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems.

We apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

Sysmex Inostics, a subsidiary of Sysmex Corp. is a molecular diagnostics company that is a pioneer in blood-based cell-free tumor DNA testing in oncology.

Our highly sensitive OncoBEAM and SafeSEQ technologies can detect minute amounts of mutant DNA circulating in the bloodstream.

With these technologies we support clinical researchers and oncologists with therapy selection and monitoring of response, recurrence as well as resistance.

Responsibilities

to build a promising future.

Responsibilities

We currently have a great opportunity for a Specialist, Quality Assurance. T he overall purpose of this position is to assist with maintenance and improvement of the Quality Management System (QMS) of the Service Laboratory in Baltimore, MD under CLIA and NYSDOH guidelines and regulations.

This position will report to the Manager, Quality Systems in Baltimore, MD.

Essential Duties and Responsibilities :

Support document control system, including document implementation, coordination of SOP reviews, and archival.

• Coordinate training and technologist competency assessments
• Maintain on-site employee files with periodic reviews and updates
• Assist with quality review of internal documentation, such as equipment records, and testing records
• Assist Quality Assurance and Laboratory Staff with internal audits and external audits
• Assist with quality systems improvement activities related to CLIA compliance, such as LIMS implementation
• Other duties as assigned to support Laboratory Operations and Regulatory compliance

Physical Risk : Regular exposure to risk that may require alertness, but with minimal precautions.

Physical Demands : Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work.

May require periods of moderate discomfort due to noise, dust, lighting and / or other conditions.

Qualifications

• Bachelor's degree or 2-4 years required experience in scientific or regulatory field, which may include experience in the Armed Forces.
• 1-2 years of experience in a regulated industry, preferably in the medical field
• Experience with for ISO 9001 or ISO 13485 a plus.
• No foreign language skills required, but, German Language a plus,
• MS Office Suite
• Highly organized
• Must be able to communicate effectively
• Must be able to work independently on assigned tasks

Sysmex's COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by your start date.

To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual's ability to provide proof of current vaccination status.

Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job.

Sysmex is proud to be an EEO / Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression , color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law.

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Last updated : 2024-03-02