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Quality Assurance Specialist (3rd Shift)

Company: US03 Lonza Walkersville Inc.
Location: Walkersville
Posted on: May 16, 2022

Job Description:

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. -Lonza is adding a Quality Assurance Specialist to the 3rd shift team to support our facility in Walkersville, Maryland. - This QA "on the floor" Specialist reports to the Liquid Media Supervisor. -The primary setting is the Production floor and major duties include providing real-time support directly or indirectly to all areas. - Other duties include making decisions related to execution of GMP-related activities while demonstrating an understanding of Quality Systems, Manufacturing practices, Good Documentation Practices (GDP), with professional and effective communication and listening.Key responsibilities: -QA oversight of Facilities and Engineering work within the GMP areas and areas that impact GMP production.Make decisions regarding both simple and complex events within the GMP environmentReview of Batch Records on the Production floor ensuring completeness, accuracy of routine work as well as footnotes / comments documented by Production staff.Performs a variety of routine work within established policies and proceduresProvides training and mentoring for less experienced staff.Database management, organization and record keeping of multiple projects.Additional process improvement projects may be assigned for independent work. -Key requirements: -High School Diploma or GED requiredWorking experience with or working knowledge of QA in a GMP or similar manufacturing environment and product management required;Biotechnology manufacturing background, preferredGMP compliance and Part 11 compliance knowledge, requiredOversight and some working knowledge of aseptic processing, requiredExcellent written and oral communication for accurate and legible documentation requiredWorking knowledge of Microsoft Office requiredMust be able to multi-task and make good decisions in this high-pace environmentMust be team-oriented with a professional demeanor, understanding deadlines with a strong sense of urgencyMust be able to walk, sit and stand for several hours; kneel, squat, bend, climb stairs and ladders as needed; Must be able to lift up to 50lbs.Must be able to train on day-shift for up to two weeks then work third shift schedule after completing training: Sunday - Friday 11:00 PM to 7:30 AM (with shift differential)Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. - -People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. -Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.?

Keywords: US03 Lonza Walkersville Inc., Germantown , Quality Assurance Specialist (3rd Shift), Other , Walkersville, Maryland

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