Warehouse Operator, CVRM (Holly Springs)

Roche•South San Francisco, CA

1d•Onsite

About The Position

Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche’s ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity Pre-Startup: As a Holly Springs Warehouse Operator, you are responsible for the comprehensive and timely ramp-up of all warehouse-related equipment, processes, and systems, ensuring full compliance with cGMP requirements throughout the design, qualification, and validation lifecycle. The warehouse will be highly automated and this role will act as user representative for SAP/eWM, the Automated Storage/Retrieval System (ASRS), and other IT systems for inventory management. This includes defining specifications and processes requirements, testing, local procedure authoring, and training the warehouse team. Support the Warehouse team in User Acceptance Testing (UAT) for the ASRS and SAP/eWM, identifying physical or logic errors during "dry run" material movements. Participate in the review and training of new Standard Operating Procedures (SOPs) for receiving, sampling, and shipping to ensure they are practical for daily floor operations. Assist in the physical organization of the warehouse, including the installation of safety signage, labeling of rack locations, and organizing the pallet exchange area. Support the commissioning of forklifts and pallet exchangers, ensuring all equipment is calibrated and ready for GMP use. Complete intensive training on ASRS safety protocols, lockout/tagout (LOTO) procedures, and high-density storage safety. Identify and report potential safety hazards or ergonomic concerns during the initial equipment setup and 'dry run' phases Post-Startup: Following the successful go-live and validation, you will transition into the Warehouse Operator role responsible for running a high volume GMP warehouse. Efficiently manage the end-to-end inbound flow: unloading trailers via forklift, executing pallet exchanges to meet ASRS specifications, and monitoring the Warehouse Control System (WCS) to ensure successful system induction. Act as the first line of defense for ASRS logic errors or physical jams, escalating technical issues to the Supervisor or Maintenance as needed. Perform real-time data entry in SAP/eWM for all material movements to ensure near-100% inventory accuracy and "Right First Time" documentation. Retrieve pallets from the ASRS handoff point and manually load finished goods onto outbound trailers for distribution to patients. Assist in monitoring temperature-controlled storage areas and responding immediately to any excursions or alarms. Willingness to work flexible shifts (including nights or weekends) as the Holly Springs site ramps up to 24/7 manufacturing operations. Maintain a high standard of cleanliness and organization (5S) within the warehouse and pallet exchange areas to ensure the facility remains "audit-ready" at all times. Accurately complete electronic records (ALCOA+ principles) for equipment cleaning, room logs, and material status labeling.

Requirements

Associate degree or vocational certification in Logistics or Supply Chain or High School Diploma/GED with 2 years relevant experience.
Experience in a GMP warehouse (Pharma, Biotech, or Med-Device) and an understanding of GMP documentation standards.
Proven experience operating forklifts (reach truck, pallet jack, or sit-down) in a high-volume setting.
Ability to use handheld RF scanners and perform basic transactions in a Warehouse Management System (WMS) like SAP/eWM.
Ability to work in varying temperatures and lift up to 50 lbs as part of routine dock operations.
Strong attention to detail ensuring that labels, part numbers, and quantities match SAP records exactly to prevent batch mix-ups.
A proactive approach to safety, especially when working around high-speed automated machinery (ASRS).

Nice To Haves

Experience working with automated warehouse systems.

Responsibilities

Comprehensive and timely ramp-up of all warehouse-related equipment, processes, and systems, ensuring full compliance with cGMP requirements.
Act as user representative for SAP/eWM, the Automated Storage/Retrieval System (ASRS), and other IT systems for inventory management.
Define specifications and processes requirements, testing, local procedure authoring, and training the warehouse team.
Support the Warehouse team in User Acceptance Testing (UAT) for the ASRS and SAP/eWM, identifying physical or logic errors during "dry run" material movements.
Participate in the review and training of new Standard Operating Procedures (SOPs) for receiving, sampling, and shipping.
Assist in the physical organization of the warehouse, including the installation of safety signage, labeling of rack locations, and organizing the pallet exchange area.
Support the commissioning of forklifts and pallet exchangers, ensuring all equipment is calibrated and ready for GMP use.
Complete intensive training on ASRS safety protocols, lockout/tagout (LOTO) procedures, and high-density storage safety.
Identify and report potential safety hazards or ergonomic concerns during the initial equipment setup and 'dry run' phases.
Efficiently manage the end-to-end inbound flow: unloading trailers via forklift, executing pallet exchanges to meet ASRS specifications, and monitoring the Warehouse Control System (WCS) to ensure successful system induction.
Act as the first line of defense for ASRS logic errors or physical jams, escalating technical issues to the Supervisor or Maintenance as needed.
Perform real-time data entry in SAP/eWM for all material movements to ensure near-100% inventory accuracy and "Right First Time" documentation.
Retrieve pallets from the ASRS handoff point and manually load finished goods onto outbound trailers for distribution to patients.
Assist in monitoring temperature-controlled storage areas and responding immediately to any excursions or alarms.
Maintain a high standard of cleanliness and organization (5S) within the warehouse and pallet exchange areas.
Accurately complete electronic records (ALCOA+ principles) for equipment cleaning, room logs, and material status labeling.