Qc Data Reviewer - Monza, Italia - Thermo Fisher Scientific

Thermo Fisher Scientific

Azienda verificata

Monza, Italia

3 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

You will join the Quality Control Team that supports a newly established mRNA-based drug production unit.

As a QC Data Reviewer, you will bring analytical skills and knowledge of GMP, to help the team in ensuring the GMP review of QC mRNA analytical documentation and logbooks.

You will have the opportunity to train, support and guide technicians to ensure compliance and in managing documentation.

You will be specifically involved in the following activities:

Responsibilities:

To perform GMP data review quality control analytical testing of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies.
To provide support and training for QC Analysts to ensure that there is understanding of why any corrections are required and how to better present data in future.
To author and review technical documentation including but not limited to standard operating procedures, investigations and reports.
To review QC logbooks for accuracy and completeness.
To maintain own training records and support and train other team members as required.
To participate in continuous improvement activities and look for further opportunities to progress the team/department.
Ensure cGMP is applied in their area of work and follow cGMP in all areas of the business.
To carry out any other tasks which may be required from time to time.

Minimum Requirements/Qualifications:

Degree in Biotech or strongly related scientific field would be an advantage
Experience in a GMP Quality Control lab and with the following techniques:
Sanger sequencing
Nucleic acid quantification by UV
RiboGreen fluorescent nucleic acid stain for quantitating intact RNA
Nucleic acid identification by agarose electrophoresis gel
Compendial test (pH, osmolality, container content, appearance)
Ability to work to critical timelines
Effective interpersonal skills and attention to detail

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 efficiency 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 of more than 100,000 colleagues 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.