Clinical Quality Packaging Operator (ONSITE)

Please note that this is a long term contract position with benefits. Must have experience with Quality and authoring or editing SOPSNote: this position is full-time (5 days/week) on site at Rahway, NJ. Infrequent travel to West Point, PA for specific business activities is also required. Hours would likely be 8-4:30 or perhaps 7-3:30.BASIC FUNCTION:Responsible for performing all activities associated with timely packaging, labeling, warehousing, and distribution of bulk and finished good clinical materials. Also responsible for Compliance and Quality-related aspects of Global Clinical Supply Operations, including metrics capture, inventory management and ordering, Standard Operating Procedure (SOP) authoring, and supporting investigations and internal inspections.Duties and Responsibilities (including but not limited to):Performs Packaging, Warehousing, and Distribution activities according to GMPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies:Primary and secondary packaging of drug products, and secondary packaging of biologics and vaccinesDistribution activities, such as order processing, drug picking/packing/shippingWarehousing activities, such as bulk and component inventory movement and accuracyManage the ordering and inventory levels for consumablesSupports Quality oversight to the Operations area through the following:Authoring or revising SOP'sSupporting batch record reconciliation / review activitiesSupporting investigations with a focus on true root cause, and creation of appropriate corrective and preventative actions (CAPAs)Participate as subject matter expert during internal or external audit from Quality group, safety bodies or regulatory agenciesSupports creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles. May liaise with other functions in Global Clinical Supply (GCS) or other partner groupsUndertake specific projects within the group on as needed basisEducation and Work Experience:Bachelor's degree in life science or related discipline, or 5+ years equivalent work experience in related industry.Knowledge, Skills, and Abilities:Understanding of Good Manufacturing Practice (GMP) principlesKnowledge of quality and safety requirements for pharmaceutical packaging / handlingDetail-oriented and organizedExcellent verbal and written communication skillsSAP experience is highly desiredExperience with Microsoft applications (Word, Outlook)Applicants must provide their phone number. Reference job number A3161.