Quality Control Analyst

Job Title: QC 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.
• 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)
• 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.
• 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.
  
  

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.