QC Chemical Analyst

04 ago - Monza
Thermo Fisher Scientific

Work Schedule

Standard (Mon-Fri)Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting

This role will:

- Ensure continuity of GMP release testing activities supporting manufacturing and batch disposition (e.g: HPLC, UV, Karl Fisher).

- Ensure timely execution of stability testing in accordance with regulatory commitments and approved stability programs.

- Maintain laboratory capacity to support strategic customers, including MSD and Novo Nordisk, avoiding delays in product release and customer deliveries.

- Support compliance with GMP requirements, internal procedures and data integrity expectations.

- Mitigate the risk of increased workload on the existing analytical team, preventing delays, overtime, reduced flexibility and potential quality risks.

Main activities carried out by the QC Analyst:

Release Testing

- Execution of routine GMP analytical testing for commercial batch release.

- Documentation of analytical activities according to GMP requirements.

- Review of analytical data and completion of laboratory documentation.





- Investigation support for laboratory deviations and atypical results.

Stability Testing

- Execution of stability analyses according to approved stability protocols.

- Management of scheduled stability testing to ensure compliance with regulatory commitments.

- Documentation and review of stability data

Other responsibilities

- Support laboratory investigations (Deviations, OOS, OOT and LIRs).

- Support equipment qualification, calibration and routine maintenance activities.

- Execution of method verification activities when required.

- Support continuous improvement initiatives and laboratory compliance activities.

- Collaboration with Production, QA and other QC functions to ensure timely product release.

Other requirements:

- Minimum 2 years of previous experience in relevant field.

- Availability to work on the first shift (6:00–13:30) and second shift (13:15–20:45).

- Preferred education: diploma in Chemistry, or Degree in Chemistry/Pharmacy/Ctf

- Basic knowledge of English (A2 level); Fluency in Italian

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