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Raritan, NJ, US

SEROLOGIST I - 2ND SHIFT-9840121121

Description

Ortho-Clinical Diagnostics is currently recruiting for a Serologist I, Second Shift located in Raritan, NJ.

Ortho-Clinical Diagnostics, Inc. provides in vitro diagnostic products to hospital, commercial and clinical laboratories, and blood donor centers. Its products include reagents and instrument systems used in blood typing and donor testing; clinical chemistry determinations and immunoassays for disease diagnosis and therapy management; as well as RhoGAMŪ, an injectable drug used to prevent hemolytic disease of the newborn.

The Serologist I will perform Serology Testing for in-process product to ensure product is meeting specifications. Read and understand technical documentation associated with specific disciplines. Identify areas for process improvement including safety, environmental, quality, compliance, productivity and cost. The Serologist will be responsible for the execution of QC test methods for product release, stability, protocols and composition of reports and methods. The Serologist will make independent decisions on execution of experiments and protocols and also on test results which will be used for product release and to determine shelf life of products. Cross-functional decisions related to products, safety, purity, potency, and efficacy.

Work with Manufacturing Operations, Process Engineering, Quality Assurance, Product Support and Validation departments to implement process improvements. Assist with equipment startup and technical training. Participate in activities for summary reports, Nonconformance's, CAPA, and Change Orders in quality control. Participate in failure investigations and customer complaint testing. The Serologist I will perform and maintain equipment calibration, qualification, maintenance and train laboratory personnel in the QC process.

Assure regulatory compliance and technical feasibility. Provide technical support to investigation and resolution of process deviations. Maintain, complete and review batch records. With guidance from Senior Serologists, conduct investigations and studies to troubleshoot manufacturing problems. Document results in technical memos. Collect, track, and trend environmental hazard training must be completed. This is not an exhaustive, comprehensive listing of job functions. The Serologist may perform other duties as assigned.

Qualifications


A minimum of an Associates degree is required. Bachelors degree and/or equivalent experience strongly preferred. A degree in Medical Technology, a scientific degree and/or equivalent experience is preferred. A Medical Technology certification is preferred. The qualified candidate will have at least 6 months work experience OR an internship OR a co-op in a related field is required. Training in a commercial production facility, Hospital or Blood Bank environment is required. Knowledge of cGMP's or FDA regulations is an asset. Experience with automated systems such as AutoVue, ProVue is also preferred. This is second shift, 2PM-10:30PM, position and will require the flexibility to work other shifts and/or weekends, as needed by business. This position will require the ability to lift up to 50lbs. This position will be based in Raritan, NJ.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Raritan
Organization: OCD Inc. (6118)