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Danaher Corporation QA Specialist (Batch) in Duncan, South Carolina

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, you’ll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall 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 Overview

The QA Specialist (Batch) works as part of Quality Assurance team and will mainly be responsible for the batch record review and final product release and certification. This person will also assist with the maintenance of quality data, creation of sample plans and other routine Quality Assurance tasks.

Job Responsibilities

  • Review batch documentation records to ensure goods are being released in compliance with the current specifications and internal procedures in a timely and detailed manner

  • Review Certificates of Sterility / Irradiation to ensure that goods are treated according to the validated settings

  • Review customer facing documents to assure GMP compliance

  • Data analysis and implementation of continuous improvement plans

  • Certify finished goods for release to customer; Initiate Supporting activities for GDP and RFT actions; Reject non conform goods according to current procedure

  • Support quality investigations of cGMP products

  • Perform internal auditing and quality inspections routinely on the shop floor as preventive measure; Support customer audits regarding questions related to batch release

  • Coordinate, maintain and participate in the Kamishibai auditing system at Gemba related to quality aspects

  • Identify, investigate and prepare reports on quality issues

  • Initiate and follow-up on CAPA's related to Internal Deviations

  • Maintain effective communication and partnership with other departments

Minimum Qualifications

  • Bachelor’s degree in a scientific field, preferably in Life Sciences (Bio, Biomedical, Chemical, Pharma) or similar

  • 1-3 years of experience in a quality and production environment

  • Good knowledge of GMP Requirements, including Good Documentation Practices

  • Familiar with Microsoft Office

  • Knowledge of Six Sigma tools and SAP, preferred

  • Knowledge of quality standards (e.g. ISO 9001), preferred

  • Will follow the applicable Health and Safety policy, safety rules and working instructions

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

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 is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

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

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.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 (https://www.dol.gov/agencies/ofccp/posters) .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 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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