Sigmar are looking for a Senior QC Analyst for a biopharmaceutical company.
As Senior QC Analyst you will be involved in the QC Chemical and Analytical Sciences (CAS) team to ensure all testing is performed as per regulatory requirements, cGMP and site procedures. In this context, your tasks will be:
- Testing stability and finished product samples, Eg Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing (Sub Visible, Protein Concentration and Polysorbate – preferred)
- Support Analytical Technical Transfer activity testing reports and documentation.
- Document review/updates, Peer-Review work
- Review and authorisation of Lab Data
- Possibility of testing of raw materials (not key focus, small part – Pharmaceutical Compendia)
- Monitoring of site water and Nitrogen systems
- Equipment Maintenance and Trouble Shooting
- Method Validation/Verification
- Laboratory Investigation support
- Laboratory Housekeeping and maintaining GLP standards
- Assisting in regulatory audits
- Training of QC Chemistry Laboratory colleagues
The next Senior QC Analyst must have a degree in the chemistry area, and 2 year ‘experience in a similar position.
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