Quality Specialist II, Lot Disposition
Company: Life Technologies
Location: Cambridge
Posted on: March 15, 2023
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Job Description:
Cambridge, MA - Reporting to the Head of QA Lot DispositionHow
you will make an impact?The Quality Assurance Lot disposition
professional will be a point of contact for the customer on all
matters related to Quality Assurance Lot Disposition. This position
requires a highly motivated, tenacious, self-starter who can
assimilate new information quickly and enjoys working closely with
others within a fast-paced project execution environment. The
individual will perform activities in support of dispositioning
product while ensuring compliance with Thermo Fisher directives and
procedures, customer requirements, and regulatory standards!What
will you do?--- Provide quality expertise and oversight of the
batch disposition process.--- Responsible for compilation and
review of batch release documentation packages.--- Works
collaboratively with manufacturing and cross-functional partners to
ensure deliverables are met to support disposition.--- Represent
the organization and act as SME during external (client and
regulatory) inspections as needed--- Responsible complaint
investigation and resolution.The QA Lot Disposition professional is
responsible for oversight of lot disposition at the Cambridge
facility. This individual will work closely with the Quality
Operations team to ensure timely and compliant release of batches.
The incumbent must be a strategic thinker, excellent communicator,
collaborative and possess the ability to make sound, time-sensitive
decisions in support of the operations.How you will get
here?Education/Experience--- Bachelors degree required with 2 years
experience in a GMP environment.Knowledge, Skills, Abilities---
Knowledge of FDA/EMA regulatory requirements applicable to
biologics or pharmaceuticals.--- Experience with Quality oversight
of batch disposition.--- Excellent organizational skills and
analytical and problem-solving abilities, strong verbal and writing
skills and good interpersonal and leadership skills.--- Possesses
outstanding time management and multi-tasking abilities to meet
commitments and target dates.Our Mission is to enable our customers
to make the world healthier, cleaner and safer. Watch as our
colleagues explain 5 reasons to work with us. As one global team of
90,000 colleagues, we share a common set of values - Integrity,
Intensity, Innovation and Involvement - working together to
accelerate research, solve complex scientific challenges, drive
technological innovation and support patients in need.
#StartYourStory at Thermo Fisher Scientific, where diverse
experiences, backgrounds and perspectives are valued.Apply today!
http://jobs.thermofisher.comThermo Fisher Scientific is an
EEO/Affirmative Action Employer and does not discriminate on the
basis of race, color, religion, sex, sexual orientation, gender
identity, national origin, protected veteran status, disability or
any other legally protected status.Accessibility/Disability
AccessJob Seekers with a Disability: Thermo Fisher Scientific
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Messages left for other purposes, such as not being able to get
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response.Job CategoryQualityThermo Fisher Scientificis an
EEO/Affirmative Action Employer and does not discriminate on the
basis of race, color, religion, sex, sexual orientation, gender
identity, national origin, protected veteran status, disability or
any other legally protected status.
Keywords: Life Technologies, Cambridge , Quality Specialist II, Lot Disposition, Other , Cambridge, Massachusetts
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