OverviewWork Schedule: Standard (Mon-Fri)Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards. In Cleanroom, no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. allowed. Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).Job DescriptionThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 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 analytical challenges, growing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.Thermo Fisher"s mRNA unit in Monza is looking for a Quality Operations Specialist!ResponsibilitiesDeviations managementExamines and handles Deviations and Investigations with the various company functions to define the causes and implement the corrective action plan within the timeframes set by technical agreementsFollow the CAPA system resulting from investigationsProvides customers with support via TLC and e-mail, promptly responding to questionsParticipates in the drafting of FMEAsThey act as SME and QO referent for the assigned projects, representing the reference quality figure and support for Customers and internal departments in order to guarantee the success of the projects and the manufacturing/disposition of GMP batchesWork in achievement of objectives for the part of their competence, and of the RFT, Deviation Rate, Past due, Ontime closure objectivesQuality On The FloorProvide active Quality On The Floor (QotF) support to manufacturing operations - by being present on the floor e.g. observing critical processes, performing visual inspection, and offering support in the flow of workReview and provide feedback on documents such as Batch Records, logbooks, and other GMP data/records while being present on the floorAssist in timely resolution for quality-related issues and compliance concerns as a first responder (e.g. part of the RAPID respond team). If any issues or concerns arise, it is important to report them immediately to the Quality Assurance and/or Operations teamsContribute to self-inspection and process audits on the shop floor and work closely with operations partners and GEMBA colleaguesHandle batch record efficiency data where relevant (e.g. turnaround time, cycle time, backlog, efficiency, document RFT trending if needed)Perform daily quality assessments/checks of classified/non-classified areas to detect errors or deficiencies. Lead by example, always demonstrate a Quality approachOther key tasksLead and apply the highest standards of Data Integrity / Good Documentation Practices in our processes e.g. supporting document completeness, accuracy, and compliance (including online review of coordinated LIMS, PIMS and CofA generation or similar)Write, review, and approve documents such as Standard Operating Procedures and Work InstructionsParticipates in customer visits and quality inspections (Audit) and internal and regulatory inspectionsIdentify and contribute to process improvement initiatives (PPI) and continuous improvement projectsRequirementsDegree in CTF, Pharmacy, Chemistry, Biology, or related scientific field, or equivalent experience in the same domainsKnowledge of pharmaceutical production and quality controlFamiliarity with GMP/FDA regulationsProficiency in written and spoken Italian and EnglishStrong teamwork, organizational, and interpersonal skillsAvailability for working on shift (Mon-Fri)Join us at Thermo Fisher Scientific to contribute to world-changing work and build an exciting career. Apply today at http://jobs.thermofisher.com.Thermo Fisher Scientific is an equal opportunity employer and is committed to providing resources and opportunities for the success of our diverse workforce. We value integrity, intensity, innovation, and involvement in our pursuit of enabling our customers to make the world healthier, cleaner, and safer.
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