Job Posting: Quality Control Analyst I
At Cepheid, we are passionate about improving healthcare through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Job Details
Job Title: QC Analyst I
Category: Quality & Regulatory Affairs
Job ID: R1254932
Location: Bengaluru, Karnataka, India
Job Description
This position is part of the Quality Organization and will be in India. Reporting directly to the Quality Control lead or site lead, the Quality Control Analyst is responsible for managing the day-to-day activities of the quality control function
at Cepheid India Private Ltd.Responsibilities:
- Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements.
- Conduct routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs).
- Perform inspections of incoming, in-process, and finished products.
- Compile data for documentation of test procedures and prepare reports.
- Perform calibration and maintenance of lab equipment as per requirements.
- Identify and troubleshoot product problems.
- Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
- Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
- Review records and documents for completeness and compliance with company policies and procedures.
- Support internal audit schedule, NC, CAPA for the site.
- Review production batch records, QC test results, and release products.
Requirements:
- Education and Experience: Master’s degree in Biochemistry, Molecular Biology, Microbiology, or related discipline and a minimum of 3+ years related Quality Control experience. 2+ years of experience with in-vitro diagnostics (IVD) is mandatory.
- Knowledge and skills:
- Hands-on experience on IVD product testing.
- Working knowledge of current GxP regulations for In-vitro Medical Devices and ISO 13485 QMS.
- Must be flexible to work off-shifts and weekends as per production schedule.
- Strong interpersonal skills, effective organization and communication skills are essential.
- Good skills in the English language.
- Knowledge of Microsoft Word and Excel.
- Strong multi-tasking and attention to detail skills.
Keywords: Quality Control Analyst Job, Quality Control Analyst, QC Analyst, Biochemistry, Molecular Biology, Microbiology, In-vitro Diagnostics, IVD, GxP Regulations, ISO 13485, India
