Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting
Job Description
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 fi
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