Warehouse Technician

ible for the setup and changeover of Inspection equipment within the Dispensary Facility.

• Responsible for executing requisite transactions on SAP and PAS-X as part of batch record review. Also to support the review of batch records as required.

• Responsible for performing and monitoring critical processes.

• Responsible for compliance with Aseptic Techniques, including environmental and personnel monitoring.

• Responsible for the calibration and maintenance of test equipment (eg. Balances, scales, pH meters, etc).

• Responsible for escalating issues accurately and in a timely manner.

• Support and partner with Maintenance & Engineering in relation to equipment troubleshooting when issues arise .

• Support log book review, batch record review and product disposition as required.

• Support and execute validation protocols as requested.

• Support and execute New Product Introduction activities.

• Responsible for the taking, labelling, and transport of batch related samples (Including DS Sampling support) to the agreed location as per procedure.

• Support the development of robust and accurate procedures by assisting in the review of documents (e.g. Red lining of SOPs, Batch records / EBRs, etc.).

• Prepare and assemble equipment and components for operations.

• Support picking operations.

• Receive instruction and/or guidance from Associate, Snr Associate or Area Manager.

• Responsible for processing incoming receipts per agreed schedule.

• Responsible for completing documentation and system transactions for all incoming receipts.

• Responsible for liaising directly with Procurement, QA, SQM, and QCS to resolve issues related to incoming receipts.

• Responsible for completing material movements and corresponding system transactions per agreed schedules.

• Responsible for transferring materials between locations and to and from the various Production Modules per agreed schedules.

• Responsible for completing inventory counts per agreed schedules.

• Responsible for coordinating and scheduling shipments with approved and express carriers.

• Responsible for accurately completing all documentation associated with each shipment.

• Responsible for making sure that shipments are packed per the appropriate SOP.

• Actively prioritizes individual workload based on department needs/ schedule.

• Any other reasonable duties as requested by their supervisor

Safety

• Responsible to perform all activities in compliance with Amgen safety standards and site safety procedures and raise any safety issues through a See Card and to Associate, Snr Associate or Area Manager.

• Operate all Ride on and Manual Pallet trucks and in a safe and compliant manner at all times.

• Only applies to personnel trained on fork trucks - Operate all forklifts and material handling equipment in a safe and compliant manner at all times.

Non-Conformance and CAPA

• Responsible for notifying and escalating to management when a Non Conformance has occurred

• Support creation and completion of Quality Non Conformances with appropriate staff.

• Support investigations through participation in Problem Solving activities (i.e. Root Cause Analysis)

Regulatory

• Support regulatory inspections, including information requests from management and regulatory representatives.

• Responsible for complying with cGMP's manufacturing processes

Continuous improvement & Projects

• Support Lean Transformation and Operational Excellence initiatives and participate in team meetings (i.e. Kaizen; Work Center Teams; etc.)

• Support continuous improvement in the area by identifying and recommending process/product improvements.

Business/Administrative

• Responsible to perform all activities in compliance with Amgen safety standards and site safety procedures.

• Responsible for personal GMP training compliance, ensuring all required training for a given task is up to date before performing GMP activities.

• Responsible for training of other staff, through on the job technical training.

• Responsible for development of personal annual reviews, goal setting and Individual Development Plans via the Maximizing Amgen Performance (MAP) process. Also support the MAP process by completing peer to peer feedback.

• Supply Chain Technicians are required to work a variety of shift patterns (including days, 2, 3 and 4 Rota shifts) and support afterhours requests.

Primary knowledge, skills, competencies and relevant experience

Knowledge:

• Ability to understand operation, assemble/disassemble and operate complex process equipment as per procedures.

• Knowledge of protein nature sensitivity and contamination control.

• Working knowledge at executing procedures and basic equipment handling (e.g. recognize and report malfunctions and assemble/disassemble equipment).

• Knowledgeable of GMP documentation requirements.

• Practical knowledge in continuous improvement tools and methodologies.

Skills:

• Ability to perform assignments alone and as part of a team with a high level of attention to detail.

• Computer literacy (Office/Windows/Werum/SAP/EBR) task execution.

• Proficient in intermediate mathematical skills.

• Proficient in the use of pallet trucks, powered and ride on pallet trucks.

• As applicable proficient in the use of Forklift trucks (Personnel exclusions allowed).

• Clear, concise writing skills.

• Organizational skills.

• Problem solving skills.

• Ability to interact constructively with peers in a team environment.

• Ability to understand, apply and evaluate basic chemistry, biology, and physical principles.

Competencies:

• Participation in characterization and test runs during new technology introduction

• GMP or other regulated environment.

• Working knowledge of manufacturing process in pharmaceutical/biotech industries.

• Ability to work alone and also to receive instruction/guidance from Associate, Senior Associate and Area Manager for new assignments.

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