Cepheid QC Analyst Job For MSc Mol Bio, Microbiology & Biochem, Apply Online

Cepheid QC Analyst Vacancy For MSc Mol Bio, Microbiology & Biochem, Apply Online

Cepheid QC Analyst Vacancy For MSc Mol Bio, Microbiology & Biochem, Apply Online. MSc Biochemistry, Molecular Biology, Microbiology Quality Control Analyst I Vacancy. Interested and eligible applicants can check out all of the details on the same below

Hey there, looking for some assistance with the possible interview questions and answers for the role of Quality Control Analyst – I at Cepheid? Then check them out below

Quality Control Analyst – I

Location – Bengaluru, Karnataka, India

Job Family – Quality & Regulatory Affairs

Job ID – R1241225

Job Title:  Quality Control Analyst – I

At Cepheid, we are passionate about improving health care 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.

Learn about the Danaher Business System which makes everything possible.

• 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 today activities quality control function at Cepheid India Private Ltd.
• Ensure compliance of quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements.

In this role, you will have the opportunity to:

• 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.
• Compiles data for documentation of test procedures and prepares reports.
• 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.
• 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.
• 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.

The essential requirements of the job include:

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 a mandate
• Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
• A quality competent technical person approved as per D&C act if any.

Knowledge and skills –

• Hands-on Experience in 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 maintain schedules and meet timelines)
• 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.

PREFERRED REQUIREMENTS –

• 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 Visio and Project knowledge desirable.

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Hey there, looking for some assistance with the possible interview questions and answers for the role of Quality Control Analyst – I at Cepheid? Then check them out below

1. Can you explain the importance of complying with quality control procedures such as MDR 2017, European regulations, ISO 13485, and corporate quality system requirements? Answer: Compliance with these procedures ensures that our products meet regulatory standards and maintain high-quality standards throughout the manufacturing process.
2. How would you handle routine and non-routine analysis of raw materials, in-process, and finished formulations? Answer: I would follow Standard Operating Procedures (SOPs) to conduct the necessary tests, compile data, and prepare reports. I would also ensure the calibration and maintenance of lab equipment and troubleshoot any product problems that arise.
3. Describe your experience with in Vitro Diagnostics (IVD) and how it relates to this role. Answer: I have over 2 years of experience in the IVD field, which has provided me with a strong foundation in conducting testing and analysis specific to diagnostic reagents and kits. I am familiar with the regulatory requirements and quality systems associated with IVD products.
4. How would you contribute to maintaining lab cleanliness and safety standards? Answer: I would strictly adhere to lab cleanliness protocols, ensure proper storage and disposal of materials, and follow safety guidelines to minimize risks. I would also actively participate in safety training programs and report any potential hazards.
5. Have you been involved in any continuous improvement efforts related to quality systems or products? Answer: Yes, I have actively participated in continuous improvement initiatives, both in terms of quality systems and product enhancements. I have contributed to identifying areas for improvement, implementing corrective actions, and monitoring the effectiveness of these changes.

Note: Answers should be tailored based on the candidate’s experience and knowledge.

Editor’s Note: Cepheid QC Analyst Vacancy For MSc Mol Bio, Microbiology & Biochem, Apply Online. Please make sure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of all of the latest in the industry. Follow us on all of our social media like Twitter, Telegram, Facebook and Instagram.