QC Analyst Jobs in Bengaluru at Cepheid, Apply Now!
The role of a Quality Control Analyst at Cepheid in Bengaluru plays a critical part in ensuring the accuracy and compliance of diagnostic products. From raw material testing to maintaining ISO 13485 and MDR standards, QC Analysts help maintain product integrity and safeguard patient health. With hands-on experience in IVD testing and lab compliance, this position offers impactful career growth in a global healthcare company at the forefront of molecular diagnostics.
About Cepheid
At Cepheid, we are dedicated to enhancing healthcare by providing fast and precise diagnostic testing solutions. With a mission to address complex health challenges, our team develops innovative molecular diagnostics that significantly impact patient outcomes globally. As part of the Danaher Diagnostics community, we collaborate with like-minded companies to drive solutions for major health issues, always keeping the patient at the forefront.
Job Title: QC Analyst I
Location: Bengaluru, Karnataka, India
Category: Quality & Regulatory Affairs
Job ID: R1290533
Job Description
This position is part of the Quality Organization in India and reports to the Quality Control lead. The Quality Control Analyst is responsible for managing daily quality control activities at Cepheid India Private Ltd. Key responsibilities include
ensuring compliance with quality control procedures, conducting analyses, maintaining lab equipment, and supporting internal audits.Responsibilities
- Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs).
- Competent technical staff for supervision the Testing/ analysis of diagnostic reagents & kits.
- Perform inspections of incoming, in-process and finished products.
- Performs and calibration and maintenance of lab equipment as per requirements.
- May perform special projects on analytical and instrument problem solving.
- Ensure that lab cleanliness and safety standards are maintained.
- Qualify test methods as part of new product development activities.
- Serve as a technical liaison between quality control and other departments
- Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses & Write or revise standard quality control operating procedures.
- Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
- Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions.
- Review records and documents for completeness and compliance with company policies and procedures.
- Support for internal audit schedule, NC, CAPA for site.
- Review production batch records, QC test results and release product.
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’ experience with in Vitro Diagnostics (IVD) is mandate
- Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
- Quality competent technical person approved as per D&C act if any
Knowledge and skills:
- Hands on Experience on IVD product testing.
- Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS.
- Must be flexible to work off-shifts and weekends as per production Schedule.
- Schedule orientated (able to consistently maintains schedules and meet timelines) for Quality Control
- Strong interpersonal skills, Effective organization and Communication skills are essential.
- Good skills in English language
- Knowledge of Microsoft Word and Excel
- Strong multi-tasking and attention to details skills.
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
- Able to interpret quality problem and establish practical solutions within a dynamic business environment for Quality Control.
- Experience in leading continuous improvement efforts, in both quality systems and products.
- Knowledge of the process of establishing facility QMS certifications.
- Cross functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable.
Keywords: Quality Control Analyst, Job, Cepheid, Bengaluru, Karnataka, In Vitro Diagnostics, QMS, Quality Assurance. QC Analyst Jobs in Bengaluru at Cepheid, Apply Now!
