San Mateo Metro Area, CA
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