Job Overview Responsible for performing routine and moderate flowcytometry assay specimen analysis. Supports troubleshooting and process improvement. Essential Functions
Performs routine and moderate analysis for flowcytometry assay specimens in accordance with assay specific gating guides (GG) and standard operating procedures (SOPs). Evaluate analyzed specimen results acceptability/rejection/cancellation. Document all corrective actions taken.
Assists in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times.
Performs and completes the daily flow specimen analysis as per the assay distribution and regional assay gating requirements.
Performs primary and secondary review of analyzed specimen results to ensure accuracy of analysis and to maintain the quality control of results analyzed.
Completes the gating assessment and proficiency testing within timeline and ensure its approval from global team.
Maintains and files analyzed data appropriately.
Maintains quality control of all analyzed data to ensure accurate and timely lab reporting.
Notifies any issue with respect to flow data analysis to senior designated staff and global cytometry team for correction.
Performs pending workload review on daily basis, finds pending assays and resolves outstanding work prior to the completion of analysis for the day and notify the same to region.
Supports cross functional projects and assists with implementation of process improvements/changes.
Coordinates and communicates with all regional labs/departments/global teams for query resolution/pending requirement/Sponsor data request.
Participates in continuing education through self-study, attending training sessions and lectures and meetings.
Supports internal and external audits and inspections, as required.
Supports safety, quality, and 6S requirements and initiatives.
Complies with company\'s procedures and applicable regulatory requirements.
Qualifications
Bachelor\'s Degree Or
Other equivalent combination of education and experience
1 year of experience in a biomedical laboratory operating under FDA guidelines.
Sound knowledge of practical application of biomedical or medical laboratory sciences and principles.
Strong technical knowledge of laboratory equipment, instrumentation and terminology used in the area of responsibility.
Proficiency in scientific and data analysis with a keen attention to detail.
Ability to troubleshoot laboratory data and resolve issues.
Good computer skills along with Microsoft Office.
Ability to maintain effective reporting procedures and control workflow.
Capable of handling multiple tasks simultaneously.
Effective organizational and interpersonal skills.
Effective communication and presentation skills.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Applicable certifications and licenses as required by local regulations.
Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://q2labsolutions.com/careers
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