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GEHC - Manufacturing Technician III

Company: Select Source International
Location: South Plainfield
Posted on: May 16, 2022

Job Description:

Job DescriptionTitle - Pharma Manufacturing TechnicianJob description (feel free to attach) - see belowTentative start date - 28 Mar 2022Tentative end date - 29 Sep 2023Work shift (days/times) - Mon - Fri / 6:00 to 2:30Client Worksite location/full address - 900 Durham Ave, South Plainfield NJ 07080Required skill set - attention to detail, lift 35lbs, ok with working with radiation, knowledge of GMPsIs this a temp to perm position - NoA brief overview of your facility and what you produce - Small site with 18 people working here, manufacture CardioGen, a radioactive drug used in the diagnostic imaging of the heart. We manufacture 2 batches per week.Essential ResponsibilitiesKey responsibilities/essential functions include:---Process, assemble, dispense, assay and package radio chemicals,radiopharmaceuticals or radioactive devices in accordance with establishedprocedures.---Knowledge of all preparations and manufacturing procedures for the formulation offinal product.---Assists in training and development of other technicians.---Accurately review and complete all batch records and related documentation.---Preparation and set-up of associated equipment and materials, i.e. ion chambers,welding units, seed counters, block heaters, autoclaves, etc.---Comply with all applicable Environmental Health & Safety (EHS), Health Physics,Quality System Requirements (QSR's) and Personal Protective Equipment (PPE)requirements.---Strict adherence to cGMP at all times.---Perform housekeeping in accordance with 5S policy perform PreventativeMaintenance (PM) as required.---Troubleshoot basic equipment problems by communicating with the LeadTechnician.---Assist in writing Investigation Reports (IR's) and initiate Unscheduled Work Orders(UWO's).---Utilize Trackwise program to document maintenance, investigations, and changecontrol actions. Utilize Medina document management system to manage webcontrolled documents.---Ability to pass all gown qualifications is required for employees who need to performwork in the dilution and filling suite.Role Summary/PurposeResponsible for providing overall direction, coordination and evaluation of 12-30manufacturing production technicians, with focus on efficiency, training and projectwork. This position supports the North American Nuclear Medicine Businessconsisting of 30 nuclear pharmacies and numerous direct hospital customers.Required Qualifications: (outline the minimum requirements)1. Associate's degree plus a minimum of 3 years experience working in a cGMPmanufacturing environment or High School diploma/GED equivalent plus a minimumof 4 years experience working in a cGMP manufacturing environment.2. Basic computer/data entry skills.3. Strong mathematical aptitude including Algebra and Geometry.4. Must understand oral/written technical English (or local language).5. Must perform shift/weekend work.6. Must be able to lift 35 lbs or more.Preferred Qualifications:1. Bachelor's degree plus 2 years experience working in a cGMP manufacturingenvironment.2. Experience working with radioactive materials and/or radioactive isotopes.3. Experience working with Access database programs and manufacturing equipmentsuch as ion chambers, autoclaves, de-pyrogen ovens, automated counters, microwelders, forklifts and semi-automated equipment.4. Previous experience in roles requiring strong attention to detail.5. Strong technical writing ability.6. Ability to multi-task.

Keywords: Select Source International, New York , GEHC - Manufacturing Technician III, Professions , South Plainfield, New York

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