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DANAHAR CORPORATION
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Analyst I - Quality Assurance

Analyst I - Quality Assurance

DANAHAR CORPORATION

5 - 7 years

6 - 10 Lacs

Bengaluru

Posted:4 hours ago| Platform:

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Skills Required

Manager Quality Assurance ISO 13485 Relationship building Trend analysis Healthcare GLP Life sciences GMP Solution architecting Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Beckman Coulter LS

Beckman Coulter Life Sciences mission is to empower those seeking answers to life s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you ll help drive our vision of accelerating answers and our commitment to excellence.

Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Position Summary and Overview:

Responsible for managing the sites Non-conformance (NC) and deviation processes. This includes reviewing and approving NC records, containing non-conforming material, conducting trend analysis, managing related CAPAs, and driving root cause investigations. The role maintains compliant Quality Management System (QMS) procedures for NCs and supports internal and external audits and inspections.

Essential Duties and Responsibilities:

Reviews and approves all aspects of Non-conformance (NC) records, including initial accuracy, dispositions, investigations, impact assessments, categorization, closure, and due date extensions, ensuring all actions are accurately recorded as per the procedural requirements.
Ensures appropriate physical segregation and labeling of nonconforming material in the designated quarantine area.
Performs trend analysis on Non-conformances to identify improvement opportunities and manages the system for Corrective Actions (CAPAs) initiated through NCs.
Participates in root cause investigations for Non-conformances and other quality issues and presents findings to management.
Responsible for the overall handling and management of product-related non-conformances and planned deviations within the site.
Maintains and monitors the Quality Management System, including site-specific and global Non-conformance procedures, ensuring full compliance with requirements, regulations, and standards.
Supports audit and inspection activities, including preparation, liaison with auditors, and resolution of findings, and performs other related duties as required.

Qualification and Experience:

Minimum Requirements:

Bachelors or master s degree in biology, Engineering or related disciplines
Minimum of 5-7 years related experience in quality assurance and/or regulatory affairs
Knowledge of ISO 13485, GMP and GLP requirements would be advantageous
Experience with handling non-conforming products and other Quality Management System processes.
Demonstrated experience in flow cytometry is crucial and will be highly advantageous.

Required Competencies:

Exceptional communication skills (verbal / written / presentation / relationship building) with ability to work collaboratively with cross-functional project teams and regulators
Ability to drive results, foster teamwork, handle pressure, and provide feedback.
Must be able to demonstrate skills in root cause investigation and problem solving.
Organized, detail-oriented with impeccable integrity.
High level of initiative, self-motivation, and energy.

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 .

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DANAHAR CORPORATION

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Analyst I - Quality Assurance