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mRNA Quality Operations specialist

  • Job
    Full-time
    Mid Level
  • Milan

AI generated summary

  • You should have a degree in a scientific field or equivalent experience, knowledge of pharma quality control, GMP/FDA familiarity, fluency in Italian and English, and strong teamwork skills.
  • You will manage deviations, support quality on the floor, review documents, assist with audits, resolve compliance issues, and lead process improvement initiatives while ensuring data integrity.

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)

Responsibilities

  • 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. 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

FAQs

What is the work schedule for the mRNA Quality Operations Specialist position?

The work schedule is standard Monday to Friday.

What are the environmental conditions associated with this role?

The role requires adherence to Good Manufacturing Practices (GMP) Safety Standards, including working in a Cleanroom environment where no hair products, jewelry, makeup, nail polish, perfume, or exposed piercings are allowed. Additionally, some degree of PPE (Personal Protective Equipment) is required.

What are the key responsibilities of the mRNA Quality Operations Specialist?

Key responsibilities include managing deviations and investigations, providing Quality On The Floor support to manufacturing operations, reviewing and approving documents like Standard Operating Procedures, and participating in customer visits and quality inspections.

What qualifications are needed for this position?

A degree in CTF, Pharmacy, Chemistry, Biology, or a related scientific field is required, along with knowledge of pharmaceutical production and quality control and familiarity with GMP/FDA regulations.

Is proficiency in languages required for this role?

Yes, proficiency in written and spoken Italian and English is required.

What skills are essential for this job?

Strong teamwork, organizational, and interpersonal skills are essential for success in this role.

Are there any specific work conditions I should be aware of?

Yes, you will be required to stand for your full shift and meet other specific cleanliness and safety requirements related to the Cleanroom environment.

Does the role require participation in audits and inspections?

Yes, the role involves participating in customer visits, quality inspections (audits), and internal and regulatory inspections.

Who is the employer for this job position?

The employer is Thermo Fisher Scientific Inc., a world leader in serving science.

How can I apply for this position?

You can apply for the mRNA Quality Operations Specialist position at Thermo Fisher Scientific by visiting their careers page at http://jobs.thermofisher.com.

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo 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, increasing 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 global team delivers an unrivaled 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.