
Laboratory Quality Assurance Specialist
1 day ago
A senior analytical quality assurance specialist plays a vital role in ensuring the accuracy and reliability of laboratory data.
- The primary responsibility is to review and verify analytical results generated by laboratory personnel, including chromatograms, method parameters, integration logs, and other technical data.
The specialist will ensure that all documents are physically available, complete, and compliant with good documentation practices.
The ideal candidate should possess strong communication leadership and technical skills in laboratory instruments like HPLC GC MS LCMS PXRD KF etc.
Key Responsibilities:
- Reviewing online sequence document reviews in HPLC GC KF PXRD ICPMS LCMS and other analytical instruments.
- Offline raw data review in ELN CD FC - Intermediate FP Stability.
- Daily verification data review PM reports and lamp intensity report review in ELN.
- Compiled report review CD FC - IPQC Intermediate FP Stability.
- Calibration sequence data review of HPLC S17 and release of instrument raw material data review and release in LIMS SAP.
- Reconciliation of EDMS issued prints formats.
- Audit trial review of standalone systems and chromeleon application.
- Monthly date time verification of approximately 20 standalone instruments.
- Review of analytical raw data generated by analyst protocols reports pertaining to the section as per standard operating procedure and specification.
- Ensuring verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.
- Review of outsourced analytical reports.
- Review of logbooks with respect to all activity performed in the lab.
Requirements:
- Good communication leadership and technical skills in Laboratory instruments like HPLC GC GCMS LCMS PXRD KF etc.
- Working knowledge in quality conducting investigations and quality management systems.
- Experience in review of data generated from QC team of QA professional required.
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