POSITION SUMMARY
Organizes and conducts quality control projects for Nittobo, under general supervision, by performing the following duties and responsibilities. All duties are performed in a manner that is consistent with the goals and policies of the company, as well as in compliance with ISO standards, where applicable.
Participates in all activities associated with inspection, testing, and release of all manufactured products prior to shipment to customers including raw batches or test bleeds. WIP batches, technical samples, and finished lots (as applicable per division).
Completes finished product testing paperwork and compiles finished product files including all finished and WIP paperwork (as applicable per division).
Participates in all activities associated with testing, inspection and release of raw materials used in the manufacturing process. This includes in-house raw, outside raw biologicals, outside sample evaluations, chemicals, and testing materials (as applicable per division).
Participates in all activities associated with testing and inspection of antigens prior to use in manufacturing programs. Including Ouchterlony, IEP, OD280 concentration, turbidimetric analysis etc. (as applicable per division).
Maintains inventory of antibodies used as reference materials.
Obtains new lots of antibodies and performs qualification testing antibody reference materials.
Maintains QC inventory of reverse RID plates and IEPs (optional per division).
Pours and performs verification of new lots of reverse RID plates (optional per division).
Participates in the training of new employees.
Performs advanced assay techniques on the automated immunoassay systems (Hitachi, AU400, C8000, Cobas Mira, Siemens Advia, etc).
Ensures proper maintenance and calibration of Quality Control equipment.
Performs equipment maintenance and calibration on assigned tools and machines as needed.
Maintains and organizes quality control records.
Creates and maintains statistical graphs and charts as required.
Assists with review and approval of CoA’s and labels.
Supports continuous improvement activities by creating and updating work instructions and forms and initiates nonconformances, corrective and preventative actions as needed.
Responsible for at least one QC inventory system.
EDUCATION and/or EXPERIENCE: Bachelor's degree from four-year college or university in biology or related life sciences; or three to four years related experience and/or training; or equivalent combination of education and experience.
NITTOBO AMERICA
Candidates must be legally authorized to work in the U.S. on and on-going basis without sponsorship.
COMPANY OVERVIEW Nittobo America Inc. was established in 1986. Our primary emphasis is the manufacturing and supply of antisera and calibrators in bulk quantities as raw material to immunodiagnostic assay manufacturers. We are ISO Certified (9001:2015).
PHILOSOPHY The people in the Nittobo Group, with regard to all corporate activities and business development, contribute to the succession of our precious global environment for the next generations, with sustainable development and by providing eco-friendly products and services.
MISSION STATEMENT To manufacture diagnostic products that create consistent value for our customers and contribute to a healthy and comfortable lifestyle; we will do this by managing our business with integrity, the highest ethical standards, and in a socially responsible manner.
Nittobo America Inc. offers competitive wages and an exceptionally strong benefits package. At Nittobo America Inc. we promote a work environment which makes the most of people's individuality. We respect the individual potential of each of our employees. Facilitated by teamwork, we aim to become a more powerful corporate entity, based on freedom of expression and the robust exchange of ideas.
Job Type: Full-time
Pay: $24.00 - $26.00 per hour
Benefits:
Application Question(s):
Work Location: In person
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