Kasim Omar
QC Analyst II
Overview
3
3
years of professional experience
4
4
years of post-secondary education
Work History
QC Analyst II
Replimune
10.2023 - Current
- Participated in departmental meetings to establish short- and long-term strategy.
- Edited, proofed and critiqued internal documents to improve clarity.
- Revival of cell lines from cell bank cryogenic-storage as well as monitoring of bank temperature.
- Performed BHK & TF-1 cell line revival and passage for use in assay.
- Handled and produce data using modified viral samples (HSV) for infection of cultured cell lines during for specialized assay's.
- Performed plaque assay, DNA extraction, QPCR and PCR Identity.
- Performed ELISA testing and data entry/trending in addition to cell counting via staining & chip hemocytometers.
- Review testing data and records of other operators and data verification for reports.
- Perform QC sample and material receipt and maintain inventory.
- Routine equipment maintenance and troubleshooting as required.
- Train other analysts within the department within scope of knowledge where applicable.
- Write or revise SOPs, protocols, FORMs and update as required.
- Write deviations related to QC and assist with investigations such as RCA, issued CAPA's, change controls and other documentation as required.
- Assist with internal and regulatory agency audits / inspections.
QC Analyst I
PCI pharma services
10.2022 - 10.2023
- Collaborated with team members and worked independently, achieving target results while maintaining H&S regulations.
- Determined root cause of deviations and non-conforming results, implemented appropriate corrective and preventive actions throughout product analytical process.
- Prepared variety of different written communications, reports and documents in accordance with client requirements. Suggested improvements or methodology and SOP's to increase right first-time documentation.
- Use of specialist software packages Empower 3, Compliancewire and Mastercontrol. Trained in use of Waters and Agilent UPLC/HPLC systems, UV-VIS spectroscopy and dissolution baths with experience in troubleshooting.
- Knowledge of ICH guidelines, with quality testing experience of clinical trial drug samples.
- Experience in principles of GMP/cGMP, data integrity and investigation and resolution of deviations such as GxP, ALCOA+, CAPA and RCA.
- Evaluated components and final products against quality standards and manufacturing specifications. Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
Laboratory Technical Officer
NHS | University Hospital Wales
06.2021 - 10.2022
- Keenly developed critical thinking and problem-solving skills, working in laboratory environments where decisions need to be made while prioritizing patient care and efficiency.
- Able to identify problems with scientific equipment and errors that may affect results and put corrective procedures into action, with supervision and autonomously.
- Experience in handling patient samples with varying degrees of urgency as well as hazardous biological specimens, reagents, and chemicals in accordance with NHS health and safety regulations.
- Work well under pressure, in circumstances where emotional resilience is tested while planning and prioritizing work.
- Experience in using complex analytical equipment to analyze biological samples wile monitoring quality control statistical charts to review performance.
- Use of Beckman-Coulter UniCel DXI 600 analyzers as well as maintenance and liaising with customer service/ call-out engineers.
- Being competent in using both internal and external control material as well as using calibrators. Experienced with UKAS accreditation maintaining audits/traceability, adhering to ISO 15189, 13485 and 9001 guidelines.
- Experienced in running services while maintaining GLP, use of laboratory management systems such as LIMS & Qpulse.
Education
Master of Science - Biomedical Sciences - Medical Biochemistry
Cardiff Metropolitan University
Cardiff 11.2021 - 11.2022
Bachelor of Science - Biochemistry
Aberystwyth University
Aberystwyth 09.2017 - 09.2020
Skills
Team Collaboration |Critical thinking and problem solving |Written & Oral Communication Skills |Effective Time Management & Adaptability | Learning Agility | Highly organized and efficient | Microsoft Office Suite | Project & People Management | Analytical & Data Analysis
Timeline
QC Analyst II
Replimune
10.2023 - Current
QC Analyst I
PCI pharma services
10.2022 - 10.2023
Master of Science - Biomedical Sciences - Medical Biochemistry
Cardiff Metropolitan University
11.2021 - 11.2022
Laboratory Technical Officer
NHS | University Hospital Wales
06.2021 - 10.2022
Bachelor of Science - Biochemistry
Aberystwyth University
09.2017 - 09.2020
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