Quality Assurance Specialist (3rd Shift)
Company: US03 Lonza Walkersville Inc.
Location: Walkersville
Posted on: May 16, 2022
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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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