Operations Technician
Summary:
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. Note:
This position is full-time (5 days/week) on site at RY. Infrequent travel to WP for specific business activities is also required. 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 vaccines Distribution activities, such as order processing, drug picking/packing/shipping Warehousing activities, such as bulk and component inventory movement and accuracy Manage the ordering and inventory levels for consumables Supports Quality oversight to the Operations area through the following: Authoring or revising SOP's Supporting batch record reconciliation / review activities Supporting 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 agencies Supports 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 groups Undertake specific projects within the group on as needed basis Education 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) principles Knowledge of quality and safety requirements for pharmaceutical packaging / handling Detail-oriented and organized Excellent verbal and written communication skills SAP experience is highly desired Experience with Microsoft applications (Word, Outlook)9393206
