Operations Technician

Job Summary:The Operations Technician I is responsible for executing technical tasks and supporting operational activities. This role requires strong organizational skills and attention to detail. This role is 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.Key Responsibilities:• Maintain cGMP and safety training to site requirements.• Follow cGMP, Standard operating procedures and safety requirements in all activities.• Operation in cold vaults, walk in CTUs, and stand up CTUs.• Execute assigned technical tasks and follow up on their completion.• Collaborate with team members to ensure operational efficiency.• Maintain accurate documentation related to technical activities.• 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.• Performs all tasks related to clinical label printing production.• 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:o Authoring or revising SOP's.o Supporting batch record reconciliation / review activities.o Supporting investigations with a focus on true root cause, and creation of appropriate corrective and preventative actions (CAPAs).o 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.• Ability to repetitively lift, carry, push and pull up to 50 lbs. required for Packaging and Warehouse roles.• Training on forklift and pallet jack use.• Demonstrate competency and in-depth knowledge of all processes, methods and procedures related to GMP environment and area-specific tasks.Qualifications:• Bachelor's degree preferred; candidates with relevant experience may be considered.• 0-3 years of experience in a related field; candidates without a degree should have 3+ years of relevant experience.• Experience using/wearing respiratory equipment• Understanding of Good Manufacturing Practice (GMP) principles.• Knowledge of quality and safety requirements for pharmaceutical packaging / handling.• SAP experience is highly desired.General Skills:• Strong organizational and detail-oriented skills.• Equipment operation and repair skills.• Problem-solving and troubleshooting abilities.• Ability to quickly learn new systems required.• Demonstrate competency and in-depth knowledge of all processes, methods and procedures related to GMP environment and area-specific tasks.