QC Analyst at Cepheid – Mol Bio, Biochem & Microbiology Apply Online

QC Analyst at Cepheid – Mol Bio, Biochem & Microbiology Apply Online

About Cepheid:

At Cepheid, we are passionate about improving healthcare through fast, accurate diagnostic testing. Our mission drives us every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. As a member of our team, you can make a measurable impact on a global scale while fostering your career growth and development. Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies, driven by the knowledge that behind every test there is a patient waiting.

Location: Bengaluru, Karnataka, India

Category: Quality & Regulatory Affairs

Job ID: R1257572

Job Description:

Overview:

This position is part of the Quality Organization and will be based 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:

Conduct Routine and Non-Routine Analysis:

• Perform routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs).
• Supervise the testing and analysis of diagnostic reagents & kits by competent technical staff.

Perform Inspections and Compile Data:

• Inspect incoming, in-process, and finished products.
• Compile data for documentation of test procedures and prepare reports.

Calibration and Maintenance:

• Perform calibration and maintenance of lab equipment as per requirements.

• Identify and troubleshoot product problems.
• 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.

Compliance and Audit:

• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• Follow documentation procedures and review records and documents for completeness and compliance with company policies and procedures.
• Support internal audit schedule, non-conformance (NC) and corrective and preventive action (CAPA) for the site.

Requirements:

Education and Experience:

• Master’s degree in Biochemistry, Molecular Biology, Microbiology, or a related discipline.
• Minimum of 3+ years of related Quality Control experience.
• 2+ years’ 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.
• Flexible to work off-shifts and weekends as per production schedule.
• Strong interpersonal, organization, and communication skills.
• Proficiency in English language.
• Knowledge of Microsoft Word and Excel.
• Strong multitasking and attention to detail skills.

Additional Qualifications (Preferred):

• Experience working with medical device quality systems in compliance with MDR and ISO 13485.
• Able to interpret quality problems and establish practical solutions within a dynamic business environment.
• 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. Vision and project knowledge desirable.

If you are interested in this position, please click here to apply directly through our website.

Keywords: QC Analyst at Cepheid – Mol Bio, Biochem & Microbiology Apply Online. Cepheid, QC Analyst job, Biochemistry, Microbiology, Molecular Biology, Quality Control, Regulatory Affairs, Bengaluru, Karnataka, India. Please ensure you are subscribed to the Getmicrobiologyjobs Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.