Cepheid Bengaluru QC Jobs – Biotech, Biochem, Mol Bio & Microbiology Apply Online
Quality Control Analyst
Cepheid Bengaluru, Karnataka, India
Category: Quality & Regulatory Affairs
Job ID: R1291740
Location: Bengaluru, Karnataka, India
The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements.
This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role.
In this role, you will be responsible for:
- Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance.
- Performs/monitor the laboratory equipment validation/calibration/maintenance and ensure quality control lab as per safety standards/GLP.
- Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site.
The essential requirements of the job include:
- Master’s degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3+ years related to quality control experience.
- 2+ years’ experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits
Business Schedule Requirement
Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines).
It would be a plus if you also possess previous experience in:
- Experience working with medical device quality systems in compliance with MDR and ISO 13485
- Experience in leading continuous improvement efforts, in both quality systems and IVD products.
- Required strong interpersonal skills, effective communication skills / micro-soft word and excel knowledge / strong multi-tasking skill.
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