About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: Description: Performs testing of radioactive pharmaceuticals, raw materials and/or facilities to required timescales as well as according to good manufacturing/laboratory practices (GMP/GLP) to verify product meets specifications and/or are free of damage or defects. In addition, provides experienced and qualified support to QC Technicians
Essential Responsibilities: Key responsibilities/essential functions include: • Inspect, test, or measure materials, products and/or work for conformance to specifications in compliance with documented procedures and in accordance with stipulated deadlines • Discard or reject products, material and/or facilities not meeting specifications • Report inspection results with those responsible for products, materials and/or facilities, and recommend necessary corrective actions where necessary • To supervise QC testing within the team as directed • To maintain accurate and inspectable paper and electronic records • To establish and maintain good working relationships with all internal customers • To lead or assist in non-routine analysis, report-writing and dossier amendments as required • Plan the development and validation of new equipment or procedures • Ensure QC inspection and analysis is carried out using compliant equipment to validated methods by appropriately trained staff • Develop and maintain specialized technical expertise in order to provide support for existing products and ongoing GxP operations as required • Drive LEAN implementation as required • Comply with EHS regulations & policies • Act as an authorized Quality Control signatory • May hold safety appointments
Qualifications/Requirements: Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Have knowledge and understanding of QC test procedures to ensure products conform to their specifications 5. Ensure the creation of accurate, complete and timely records
Required Qualifications: 1. University graduate (Science) with reasonable work experience OR equivalent relevant work experience 2. Reasonable laboratory experience 3. Reasonable manual dexterity 4. Experience of computer systems 5. Excellent numeric skills
Preferred Qualifications: 1. Knowledge and experience of a GxP environment or other regulated industry 2. Ability to write clear technical documentation
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