Posted in Other about 3 hours ago.
Location: Cincinnati, Ohio
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.
The Operations Quality Specialist II is a critical member of the Operations Team. The Operations Quality Specialist II's primary focus is leading department quality investigations to resolve the root cause and identify both corrective & preventative actions for top quality losses. Proactively leads quality improvements for the department.
Proactively drives quality improvements to achieve department right first time (RFT) and quality compliance goals. Participates in quality incident response, including initial response and containment, and applies Practical Problem Solving tools and principles to aid in root cause analysis and identification of corrective actions. Facilitate discussions between cross-functional teams (Quality, Tech Services, Engineering, etc.) in order to drive alignment on quality incident root cause and correction actions.
Aid in investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met. Performs final functional area approval for operations owned deviation investigation reports to ensure report accuracy and alignment on root cause and correction action(s). When appropriate, revise and maintain Manufacturing procedures and forms to ensure GMP compliance. Support Manufacturing systems to proactively identify and address quality risks, including Daily Gemba process and Quality Suggestion Program. Track and analyze Quality metric data for Manufacturing department to drive RFT initiatives.
Participates in inspection readiness activities in Manufacturing Areas.
May assist in developing and maintaining quality and training systems, such as Digital Logbook system or eBPR system. Represent Operations when appropriate in PPI Kaizens and workshops
Models effective and constructive communication and interactions with technical departments both orally and in writing. Maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills. Requires a passion for problem solving, attention to detail, good social skills, a sound understanding of cGMPs and Manufacturing/ Packaging. Ability to interact with the operations personnel, QA GMP Services, Process Engineers, Records/Release, Quality Control, QA Regulatory, Engineering.
Requirements:
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