Work Schedule Standard (Mon-Fri)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materialsJob DescriptionWorking hours: 8:00 to 16:30 - Monday to FridayDirect Report To: Supervisor, QCGroup/ Division: Protein Diagnostics (PDX) / Specialty Diagnostics Group (SDG)Career Band: 3Position Location: UK - Birmingham - 27 Sovereign RdLocation/Division Specific Information:The Binding Site Group, a part of Thermo Fisher Scientific, is a global leader in specialty diagnostics, provides diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders. The Binding Site’s Freelite® offering is widely recommended for multiple myeloma diagnosis and monitoring across all stages of the disease by major clinical guideline publications. In addition, The Binding Site is an active and influential contributor to the broader scientific community. To find out more visit www.bindingsite.comA Day in the Life:In this role, you will:Ensure regulatory and quality system compliance for components by adhering to the Quality Management System.Conduct inspections of raw materials and finished goods, perform raw materials testing, and archive inspection document records.Investigate quality and technical issues, propose corrective actions, and collaborate with other departments for resolution.Maintain and calibrate equipment, respond to product changes and new product development, and manage change orders.Complete daily work activities promptly, including control plan setup/ amendments and undertake QC process improvement projects.Raise and manage minor changes.Keys To SuccessSuccess in this role includes excellent communication, attention to detail, problem-solving abilities, knowledge of regulatory requirements, strong organizational skills, and a dedication to continuous learning.EducationGCSE Maths and English (Grade A –C) or equivalentExperienceRequired: Minimum of 2 years of work experience in QA or QC or related fieldPreferred: Experience in a cGMP environment or other highly regulated environmentKnowledge, Skills, AbilitiesExperience of QC Checking processes – either raw material, in process or finished productExcellent communication skills (both written and verbal)Excellent attention to detailAbility to plan and prioritize own workload to meet the objectives of the departmentConfident in basic use of Microsoft Office applications, especially WordPhysical Requirements / Work EnvironmentWillingness to work in various environments such as Office, Warehouse, Laboratory and Assembly area. This may involve manual handling and operating Hand Pallet Truck. This also involves wearing appropriate PPE (in the Warehouse and in the Laboratory area).Willingness to travel off-site to establishments within a 20 mile radius (infrequent).
