Sample Management Operator

• Job title- GMP Sample Management Technician
• Location -Speke.
• Shifts- 4 on 4 off shifts 06.00-18.00
• Pay- 15.07 p/h
• Contract - Contract to end Dec 2025 and then extended on rolling 12-month basis

Working in a global pharmaceutical manufacturer the Job Holder will be responsible for the timely and compliant sample management service and support warehouse operations. The Sample Management process technician will perform sample management activities and operations, to include but not limited to; sample control of routine production samples, retain and reserve samples and samples of GMP received materials.

Accountabilities:

• The documentation and control of all sample movements, good housekeeping, cGMP, health and safety, timekeeping, regulatory legislative requirements and in accordance with the rules and requirements of the GMP Compliance Rulebook, the Code of Conduct, quality manual and any other company policies and procedures (including completion and validation of LIMS electronic data), to include the investigations of deviations.
• To provide an interface / communication between UK-I laboratories and supply chain operations, internal, external customers. Liaise with the site planner and logistics coordinator to plan, track and monitor test samples in relation to product release. Collate data from the appropriate testing groups and report AFM status of drug substance.
• Act as Subject Matter Expert for sample management.
• To assist in supervision of sample management activities (including scheduling personnel and work) and to deputise for PT, as appropriate.
• Review incoming goods schedule with respect to pending GMP receipts and develop testing plans to the same.
• Monitor, track and report release status of all GMP materials.
• Participate in daily group meetings and escalate issues appropriately. Update appropriate visual factory information to communicate test sample status.
• Distribution and processing of all samples to internal and external testing groups. Develop a work schedule for incoming samples of drug product to support final release. Manage all sample shipments for the UK testing groups, distribute, and report progress as required.
• The review and approval of documentation e.g., equipment logbooks to ensure adherence to Good warehouse procedures and cGMP.
• To ensure the correct operation and ensure maintenance of equipment in the department is performed (e.g. calibration dates) whilst assisting the engineers in their duties.
• Manage control and monitoring of equipment under Warehouse and sample management control as detailed in specific SOPs e.g. BAS and freezers
• To ensure all activities performed are compliant with company Health and Safety Guidelines.
• To assist in the receipt, inspection, storage, transfer, pick, issue, disposal, shipping and distribution of all categories of goods in all areas, in compliance with all area procedures.
• To ensure all samples are taken and transferred to the relevant department with the appropriate documentation. Store and control reserve and retain material as per the requisite guidance.

Requirements

• The job holder is likely to have a good standard of education, with a minimum of 5 GCSE's/CSE including English and Mathematics.
• Substantial experience in a GMP environment preferably within the pharmaceutical/Biotechnology industry
• The role holder requires a good awareness and understanding of Good Manufacturing Practices and HS&E requirements. The role holder must have expert knowledge of cGMP standards.
• Good verbal and written communication skills, including report writing skills.
• Understanding of electronic quality systems
• Expert technical and compliance understanding of specific process stages and equipment involved. Good understanding of EHS compliance requirements for area of responsibility.
• Computer literature
• Good Organisational skills
• Good planning and time management skills, enabling individual to work under pressure and supervise activities
• Be able to influence at various levels within the organisation and to obtain support from other areas when required

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.