Quality Engineer III
Company: AbbVie, Inc
Posted on: May 3, 2021
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
The Quality Engineer III performs as QA specialist in the area
of quality assurance oversight of operations, production, process
and equipment systems and computer validation at the Waco
This position is responsible for the following:
- Providing Quality Assurance oversight and assessment of
operational activities in Production, Compliance, Validations, and
Technical Services projects.
- Serving as the QA representative on Validation and Technical
Services projects. Liaison to process and equipment validations for
QA/QC laboratories, BT, Manufacturing, and Engineering.
- Ensuring process and equipment validations meet current
regulatory expectations (cGMP compliance) by providing guidance and
executing both internal and external audits of our processes.
- Reviewing and approving equipment validation documentation
(e.g., protocols, deviations, and final reports).
- Supporting change control activities associated with processes
and equipment validations.
- Managing and coordinating QA support for new and existing
process equipment validations implementation.
- Providing CSV oversight based on the education and training of
- Providing support in defining statistical design and analysis
for process development, technology transfer, analytical
development, process validation and re-qualifications,
manufacturing, chemistry and microbiology laboratories, incoming
QA, investigations, CAPA's, compliance, complaints process.
- Supporting investigations related to process and testing
- Communicating effectively and promptly at all levels of the
- Generates appropriate purchasing (CE's) and documentation for
Quality Assurance validations projects and URS and FRS
- Performs other duties as assigned.
Minimum requirements for this position are:
- Minimum of a B.S. in Engineering, analytical, or sciences
degree from an accredited institution. Graduate Degree is
preferred. A Master's Degree may substitute for one-year
- Minimum of three (3) years of experience with a minimum of one
(1) year working in relevant areas such as process validations or
- Experience in a pharmaceutical GMP regulated environment
- Experience in an aseptic manufacturing environment
Essential Knowledge, Skills & Abilities:
- Demonstrated ability to apply analytical methods.
- Demonstrated ability to work with all levels of
- Demonstrated business acumen.
- Detail-oriented and self-motivated.
Significant Work Activities
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer we do not discriminate on the
basis of race, color, religion, national origin, age, sex
(including pregnancy), physical or mental disability, medical
condition, genetic information gender identity or expression,
sexual orientation, marital status, protected veteran status, or
any other legally protected characteristic.
Keywords: AbbVie, Inc, Waco , Quality Engineer III, Other , Waco, Texas
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