Quality Specialist II

Usa Ca - San Diego (bdb)mid

OtherQuality Specialist

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Quick Summary

Overview

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters.

Technical Tools

OtherQuality Specialist

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities

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Execute stability studies for reagent products, including sample preparation, testing according to established protocols, and data collection.
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Perform various microbiological tests on raw materials, in-process samples, and finished goods, including but not limited to bioburden, sterility, and endotoxin testing.
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Analyze and interpret stability and microbiological test results, ensuring accuracy and adherence to specifications.
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Document all testing procedures, results, and observations in laboratory notebooks and designated quality management systems in a clear, concise, and timely manner.
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Identify and investigate out-of-specification (OOS) results, deviations, and non-conformances, documenting findings and participating in root cause analysis.
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Maintain and calibrate laboratory equipment, ensuring proper functioning and compliance with quality standards.
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Assist in the development and validation of new test methods and procedures for stability and microbiological testing.
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Contribute to the continuous improvement of quality control processes and procedures.
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Adhere to all safety regulations and good laboratory practices (GLP) and good manufacturing practices (GMP).
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Collaborate effectively with R&D, Manufacturing, and other Quality Assurance teams.

Requirements

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Bachelor's degree in Microbiology, Biochemistry, Molecular Biology, or a related scientific field.
2-4 years of experience in a regulated laboratory environment, preferably in the pharmaceutical or biotechnology industry.
Proven experience with reagent product stability testing and data analysis.
Demonstrated expertise in a variety of microbiological testing techniques (e.g., bioburden, sterility, endotoxin, microbial identification).
Strong understanding of GMP, GLP, and relevant regulatory requirements.
Proficiency in laboratory instrumentation and data acquisition software.
Excellent written and verbal communication skills.
Ability to work independently and as part of a team in a fast-paced environment.
Strong attention to detail and organizational skills.
Problem-solving skills and a proactive approach to quality issues.

$83,500.00 - $133,500.00 USD Annual

What We Offer

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To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.