Warehouse Operator

Permanent employee, Full-time · Shannon

Your mission
  • To assist in managing the day-to-day activities for the Warehouse adhering to cGMP/Regulatory guidelines.
  • Carry our Goods Receipts, Labelling, and Putaway activities as per relevant SOP’s, and update location database.
  • Ensure all materials are picked/checked and ready to transfer to Manufacturing operations as described in the manufacturing schedule.
  • Prepares product(s) for shipment by verifying locations and documentation; directing movement to staging area; resolving/escalating issues as needed.
  • Perform periodic inventory checks to ensure the accuracy of database information and minimize the risk of inventory issues.
  • Verifies product inventory reports by comparing logs and reports, adjusting entries as needed.
  • Documents actions by completing forms, reports, logs, and records; maintaining databases.
  • Ensure correct material segregation is maintained based on hazard class and quality status.
  • Carry out cleaning and housekeeping duties to maintain the Warehouse area in a GMP ready state to support manufacturing and QC testing operations.
  • Updates job knowledge by participating in educational opportunities.
Job Description
Major Activities
  • Work in accordance with cGMP always.
  • Support/contribute to the teams’ effectiveness to meet operational requirements of Warehousing and Distribution facilities.  
  • Communicate effectively with all stakeholders in a supportive manner. 
  • Maintain stock accuracy of MeiraGTx Warehouse locations, minimise inventory discrepancies through cycle counts and root cause investigations.    
  • Assist with the end-to-end processes of all Warehousing activity.
  • Assist with troubleshooting any issues with supply of materials to Manufacturing.  
  • Provide support and business improvements for written procedures, SOPs etc.
  • Accountable for own Continuous Professional Development to maintain up-to-date knowledge of new technical developments relevant to own area of expertise. Proactively share knowledge with all others who may benefit from it.
  • Maintain inventory reports and documentation to ensure accurate record keeping for all materials. 
  • To assist in material impact assessment, change request, scheduling or other Supply Chain related meetings, purchasing of materials.
  • Ensure delivery schedule is maintained and promptly alert the Supply Chain Manager if a delay occurs or is likely to.
  • Ensure the weekly rota and responsibilities are followed and any issues are brought to the attention of the Supply Chain Manager.
  • Maintain stock accuracy of MeiraGTx warehouse locations, Support inventory discrepancies through cycle counts and root cause investigations.    
Responsibilities
  • Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
  • Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
  • Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.
  • Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
  • Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
  • Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.
Key Performance Indicators
  • Goods Receipts, Storage, & Transfers are accurate and completed in a timely manner.
  • Inventory accuracy is maintained in terms of quantity and storage locations.
  • Products shipped as required to GDP requirements.
  • Warehouse Housekeeping is maintained to the required standard.
  • To support regulatory inspections and ensure the Warehouse is compliant with all cGMP standards.
Key Job Competencies
  • Significant Warehouse and supply chain experience preferably in the Pharmaceutical manufacturing industry or in a similarly regulated industry.
  • Demonstrates a can-do attitude.
  • Familiarity with the requirements of a Regulated Warehouse. 
  • Customer service skills with internal and external stakeholders.
  • Diligent with an eye for detail, accurate data entry & documentation skills.
Job Background
  • High degree of accuracy, numeracy, literacy and provides a clear sense enthusiasm and energy.
  • Previous proven Warehouse experience, including materials management and materials planning and using mechanical equipment for example FLT.
  • A good understanding of all Health and Safety regulations appertaining to the Warehouse function.
  • Computer literate with Microsoft applications and ERP systems such as SAP etc.
  • Competent understanding of incoterms and logistics requirements specifically cold chain supply.
  • Challenges the status quo in a constructive and collaborative manner.
  • Actively seeks views and opinions of others, with respect and understanding for diversity.
  • Encourages initiative and the need for change.
  • An innovative and creative thinker who can turn theoretical ideas into practical actions.
  • Works and thinks in a lean and agile manner.
  • A team player, but who can also work on their own initiative, Willingness to help, support, and develop oneself.
About us

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

We are looking forward to hearing from you!
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