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QC Analyst

San Mateo Metro Area, CA

Post Date: 02/02/2017 Job ID: JN -022017-18280
An Emerging Molecular Diagnostic Company in the SF Bay Area has an opportunity for a QC Data Analyst

Position Summary:

Seeking a QC Data Analyst to work with the manufacturing team to analyze and summarize in-process and final QC data for our proprietary and leading edge molecular diagnostic products. The successful candidate will have a strong technical background in end point and real-time PCR data, strong attention to detail, and a desire to be part of an exciting, growing company.

Major Responsibilities / Essential Functions:
  • Conduct quality control analysis for in-process, finished good product, and stability of samples according to SOP (Standard Operation Procedures) and/or guidelines.
  • Compile analyzed data, interpret data and submit data summaries for review
  • Maintain detailed records and documentation
  • Identify problems that may affect test performance or results and conduct corrective action per protocols. Document corrective actions taken when test deviate from established performance specifications.
  • Work with R&D to transfer new products into Manufacturing
  • Assist in the development of QC Procedures, create and maintain QC documentation for new and existing products, processes, and equipment.
  • Ensure compliance with SOPs and ISO 13485 regulation
  • Assist manufacturing with production process
  • May perform other duties as assigned
  • Help identify and implement new process improvements. Assist in existing process improvements.
  • Adhere to all processes and procedures
  • Conduct training for new QA team members
  • Bachelor s degree in Molecular Biology, Biochemistry or related Science Filed
  • Minimum of 2 years Biotech industry work experience
  • Previous experience in QC role with significant experience in PCR
  • Proficient with Excel and other data analysis tools
  • Detail oriented, quality focused and self-motivated
  • Ability to organize and prioritize work load to meet deadlines
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