Mrna Quality Operations Specialist

Quality Operations Specialist

Thermo 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!

What will you do?

Deviations Management

• Examines 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 agreements;
• Follow the CAPA system resulting from investigations;
• Provides customers with support via TLC and e-mail, promptly responding to questions;
• Participates in the drafting of FMEAs;
• They 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 Floor

• Provide 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. Lead by example, always demonstrate a Quality approach.

Other Key Tasks

• Lead 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.
• Participates in customer visits and quality inspections (Audit) and internal and regulatory inspections;
• Identify and contribute to process improvement initiatives (PPI) and continuous improvement projects.

Requirements

• Degree 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 an exciting career.