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Danaher Corporation Quality Control Analyst I in Sriperumbudur Taluk, India

JOB DESCRIPTION

Job Title: Quality Control Analyst I

Job Location: India-Tamilnadu-Chennai

GCRF Job Family: Quality and Regulatory Affairs

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).

JOB DESCRIPTION

POSITION SUMMARY:

  • Reporting directly to the head of India Quality System and Regulatory Compliance (QSRC) manager, 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.

ESSENTIAL JOB RESPONSIBILITIES:

  • Competent technical staff for supervision the Testing/ analysis of diagnostic reagents & kits.

  • Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs).

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

  • Performs and calibration and maintenance of lab equipment.

  • Reviews data obtained for compliance to specifications and reports abnormalities.

  • Revises and updates SOPs.

  • May perform special projects on analytical and instrument problem solving.

  • Ensure that lab cleanliness and safety standards are maintained.

  • Train other analysts to perform laboratory procedures and assays.

  • Perform inspections of incoming, in-process and finished products.

  • Approves inspections of incoming, in-process and finished products.

  • Participate in internal assessments and audits as required.

  • 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.

  • Supply quality control data necessary for regulatory submissions.

  • 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.

  • Monitors internal audit schedule, NC, CAPA for site

  • Review production batch records, QC test results and release product.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

TRAINING RESPONSIBILITIES: (REQUIRED)

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience:

  • Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical field and 4+ years’ experience with increasing responsibility in Quality Control area

  • 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.

  • PREFERRED REQUIREMENTS:

  • 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.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 70,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $20 B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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