Quality Specialist, Batch Disposition*
Company: Novartis Group Companies
Location: Durham
Posted on: April 24, 2024
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Job Description:
394674BR
Quality Specialist, Batch Disposition*
USA
About the role
The Specialist, Disposition is responsible for overall quality and
disposition of incoming and make materials. This includes raw
materials, consumables, media, buffers, intermediates, drug
substance and drug product, as required.
Collaborates with suppliers to ensure incoming documentation is in
adherence to Novartis standards and specifications.
* * Collaborates with manufacturing and manufacturing quality teams
to ensure adherence to batch records, clinical protocols, and
regulatory requirements for manufactured gene therapies.
* Ensures all area documentation remains in compliance and provides
QA support for Quality Systems including deviations, CAPAs and
Change Controls.
* Provides quality oversight to warehousing functions including
performing walkthroughs, alarm reviews, inventory management, and
quality inspection of returns.
* Issues and archives batch records and forms for manufacturing
make materials.
* Contribute to the key site metrics for the Quality Management
Review meeting (QMR) to ensure a state of control and drive action
where appropriate along with reporting on a specific set of quality
and compliance metrics, reporting to management all necessary
information regarding product release.
* Supports projects to address quality gaps or drive continuous
improvement related to Operations or Quality Systems.
* Develop standard work to implement risk-based quality oversight
program for Operations and ensure routine activities are completed
within established timelines.
May process and release dose packs.
EEO Statement
We are Equal Opportunity Employers and take pride in maintaining a
diverse environment. We do not discriminate in recruitment, hiring,
training, promotion or other employment practices for reasons of
race, color, religion, gender, national origin, age, sexual
orientation, gender identity or expression, marital or veteran
status, disability, or any other legally protected status. We are
committed to building diverse teams, representative of the patients
and communities we serve, and we strive to create an inclusive
workplace that cultivates bold innovation through collaboration and
empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations: Individuals in need of
a reasonable accommodation due to a medical condition or disability
for any part of the application process, or to perform the
essential functions of a position, please let us know the nature of
your request, your contact information and the job requisition
number in your message:
Role Requirements
Bachelor's degree in engineering, microbiology, chemistry or
biochemistry with 3 years equivalent industry experience in Batch
Disposition and/or Quality Assurance in a GMP environment OR
* 3 years of experience in biopharmaceutical based GMP
manufacturing operations including direct experience in cell
culture, purification, or aseptic fill/finish.
* Experience with clinical manufacturing, viral gene therapies
and/or orphan disease indications is a plus.
* Comfortable in a fast-paced environment and able to adjust
workload based upon changing priorities.
* Self-starter with an understanding of GMP requirements, acute
attention to detail.
* Flexible hours to support patient kits is required.
The pay range for this position at commencement of employment is
expected to be between $40.38 and $60.57 hourly; however, base pay
offered may vary depending on multiple individualized factors,
including market location, job-related knowledge, skills, and
experience. The total compensation package for this position may
also include other elements, including a sign-on bonus, restricted
stock units, and discretionary awards in addition to a full range
of medical, financial, and/or other benefits (including 401(k)
eligibility and various paid time off benefits, such as vacation,
sick time, and parental leave), dependent on the position offered.
Details of participation in these benefit plans will be provided if
an employee receives an offer of employment. If hired, employee
will be in an "at-will position" and the Company reserves the right
to modify base salary (as well as any other discretionary payment
or compensation program) at any time, including for reasons related
to individual performance, Company or individual department/team
performance, and market factors.
Why Novartis: Our purpose is to reimagine medicine to improve and
extend people's lives and our vision is to become the most valued
and trusted medicines company in the world. How can we achieve
this? With our people. It is our associates that drive us each day
to reach our ambitions. Be a part of this mission and join us!
Learn more here:
https://www.novartis.com/about/strategy/people-and-culture
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and
providing reasonable accommodation to individuals with
disabilities. If, because of a medical condition or disability, you
need a reasonable accommodation for any part of the application
process, or in order to perform the essential functions of a
position, please send an e-mail to tas.nacomms@novartis.com call
+1(877)395-2339 and let us know the nature of your request and your
contact information. Please include the job requisition number in
your message.
Division
Operations
Business Unit
QUALITY
Work Location
Durham, NC
Company/Legal Entity
Novartis Gene Therapies
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
Keywords: Novartis Group Companies, Chapel Hill , Quality Specialist, Batch Disposition*, Other , Durham, North Carolina
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