Analyst II- Quality Control – Bangalore


Analyst II- Quality Control

Danaher Corporation

Bangalore

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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.

Designation: Analyst II- Quality Control

Supervisor: Team Lead Quality Control

Location – Bangalore

Position Summary and Overview:

Reporting directly to the QC Team Lead, this position will be responsible for managing the day to day activities of Quality Control function at Beckman Coulter Bangalore Development Centre. Act as the sign-off authority for all the Analytical reports and documentation going out from quality control team. Ensure compliance of Quality control procedures and activities to 21 CFR 820, ISO 13485, ISO 9001, MDSAP, Beckman Coulter corporate Quality system requirements. Support preparedness and management of external audits and inspections.

Essential Duties and Responsibilities:

+ Approves testing reports for finished goods, in process and incoming materials

+ Performs QC testing for finished goods, in-process samples and incoming materials whenever required.

+ Supports Quality Assurance in product release by providing Certificate of Analysis based on approved testing reports

+ Coordinates with manufacturing and R&D to plan QC and inspection activities

+ Supporting validation activities with respect to QC instruments by co-ordinating with technical operation and validation QA team.

+ Responsible for handling functional QMS process like Change Request, Deviation Records, CAPA Requests etc.

+ Provides guidance to employees technically and supports the work group

+ Responsible for compliance of the testing process and associates to specifications, standards and regulatory requirements

+ Ensure that the work environment (including equipments and infrastructure) is maintained adequately as per requirements.

+ Ensures procedures and work instructions are updated and current

+ Drives root cause investigations into identified problems, ensures the cause for defects are removed and drives continuous improvement

Qualification and Experience:

Minimum Requirements:

+ Master’s degree in science, medical or technical field with at least 8 to 10 years of industrial experience with increasing responsibility in Quality Control area or PhD with at least 5 years of experience.

+ Experience in flow cytometry is must. Candidate should have handled multi-parameter flow cytometry assays independently, including trouble shooting issues.

Preferred Requirements:

+ Experience working with medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485.

+ In Vitro Diagnostics (IVD) experience will be preferable.

+ Experience in leading continuous improvement efforts, in both quality systems and products.

Required Competencies:

+ Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, 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

+ Must have critical thinking skills and good judgment working in an independent environment

+ Organized and detail-oriented

+ High level of initiative, self-motivation and energy.

+ Reliable and responsive.

+ Customer focused

+ High level of integrity

+ Goal oriented, interpersonal, self-motivated and team player.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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.

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