mRNA Quality Operations specialist
6 giorni fa
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, 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.), Standing for full shift.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 SpecialistWhat will you do?Deviations managementExamine and handle Deviations and Investigations with the various company functions to define the causes and implement the corrective action plan within the timeframes set by technical agreements.Follow the CAPA system resulting from investigations.Provide customers with support via TLC and e-mail, promptly responding to questions.Participate in the drafting of FMEAs.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 batches.Work in achievement of objectives for the part of their competence, and of the RFT, Deviation Rate, Past due, Ontime closure objectives.Quality 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 work.Review and provide feedback on documents such as Batch Records, logbooks, and other GMP data/records while being present on the floor.Assist 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 teams.Contribute to self-inspection and process audits on the shop floor and work closely with operations partners and GEMBA colleagues.Handle 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. Always demonstrate a Quality approach.Other 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 Instructions.Participate in customer visits and quality inspections (Audit) and internal and regulatory inspections.Identify and contribute to process improvement initiatives (PPI) and continuous improvement projects.RequirementsDegree in CTF, Pharmacy, Chemistry, Biology, or related scientific field, or equivalent experience in the same domains.Knowledge of pharmaceutical production and quality control.Familiarity with GMP/FDA regulations.Proficiency in written and spoken Italian and English.Strong teamwork, organizational, and interpersonal skills.Availability for working on shift (Mon-Fri).Join us at Thermo Fisher Scientific to contribute to world-changing work and build a fulfilling 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.#J-18808-Ljbffr
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mRNA Quality Operations specialist
2 settimane fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, 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...
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Senior mRNA Quality Control Specialist
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoCompany OverviewThermo Fisher Scientific is the world leader in serving science, with a strong commitment to enabling our customers to make the world healthier, cleaner and safer. Our mission is to deliver innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands.Job DescriptionWe are seeking a Senior...
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mRNA Quality Operations specialist
7 giorni fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, 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...
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Mrna Quality Operations Specialist
6 giorni fa
Monza, Italia Thermo Fisher Scientific A tempo pienoWork 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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear...
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Mrna Quality Operation Specialist
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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 sophisticated analytical challenges, growing efficiency in their laboratories,...
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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 complex analytical challenges, boosting productivity in their laboratories,...
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Quality Head, Mrna Business
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Mrna Quality Project Leader
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAbout the RoleWe are seeking a highly skilled Quality Operations Specialist to join our team at Thermo Fisher Scientific's mRNA unit in Monza.The successful candidate will be responsible for ensuring the quality of our products, managing deviations and investigations, and communicating effectively with customers.Key ResponsibilitiesDevelop and implement CAPA...
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mRNA Quality Operations Specialist Role
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoAt Thermo Fisher Scientific, we are the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner, and safer.We are looking for a Quality Operations Specialist to join our team in Monza.The key responsibilities of this role include:Managing deviations and investigations to define causes and implement...
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Supervisor Quality Control Mrna
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo 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 complex analytical challenges, growing efficiency in their laboratories, improving...
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mRNA Operations Specialist with Quality Focus
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Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pienoJob DescriptionThermo Fisher Scientific is a leading company in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. We are looking for a Quality Operations Specialist to join our team in Monza.Key Responsibilities:Deviation management: Examine and handle deviations and investigations to define causes and...
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Mrna Supply Chain Specialist I
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo 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 complex analytical challenges, growing efficiency in their laboratories, improving...
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo 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 complex analytical challenges, growing efficiency in their laboratories, improving...
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Monza, Italia Thermo Fisher Scientific A tempo pienoThermo 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 complex analytical challenges, growing efficiency in their laboratories, improving...