QC Analyst ※CMIC, Inc.
QC Analyst is responsible for timely review of datasets, work sheet plans, and reports to identify and assess accuracies in accordance with applicable methods, study plan, and SOPs under the guidance of Quality Assurance Manager in support of the sponsor’s studies. Effectively communicate review findings with lab staff and Principal Investigators. Support QC team to meet group goals. Perform other QC duties as deemed necessary.
• Follow GLP requirements, company policies, SOPs and QC review procedures.
• Review study plan, datasets, work sheet and reports to identify and assess accuracies in accordance with applicable methods, study plan, SOPs under the guidance of the Quality Assurance Manager in support of the sponsor’s studies.
• Report review findings and communicate with PI and other lab staff.
• Maintain accurate records of work and study documentation per GLP Good Documentation Practices and SOPs.
• Be organized and pay close attention to detail to optimize quality data review.
• Assumes other activities and responsibilities as assigned.
Preferred 1+ years working in a GLP Bioanalysis laboratory environment with understanding of instrumentation and generated data for either small or large molecule
・Small Molecule: LC-MS/MS and/or UHPLC-UV; UHPLC-FD.
・Large Molecule: ECL - MSD S600, ELISA; ; qPCR – Quant Studio 5; and or Cytoflex – Flow Cytometer
B.S. in related field
Experience and Skills
• Understand GLP requirements, SOP/SWPs and related lab procedures; Understand data results from instruments
• Maintain quality execution and work.
• Ability to handle confidential information.
• Demonstrated effective oral and written communication skills.
• Good team player.
• Effective time management skills; complete work in a timely manner (i.e. maintain timelines).
• Proficient in MS Office and Excel and to be adept at learning new systems.
Interested parties please apply via HR@cmicgroup.com
Responsible Person Contact details
Name: Denise Washick