Quality Engineer III

Company: AbbVie, Inc
Location: Waco
Posted on: May 3, 2021

Job Description:

About AbbVie

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 facility.

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 the individual.
• 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 findings.
• Communicating effectively and promptly at all levels of the organization.
• Generates appropriate purchasing (CE's) and documentation for Quality Assurance validations projects and URS and FRS requirements.
• Performs other duties as assigned.

Qualifications

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 experience.
• Minimum of three (3) years of experience with a minimum of one (1) year working in relevant areas such as process validations or technology transfer.
• Experience in a pharmaceutical GMP regulated environment preferred.
• Experience in an aseptic manufacturing environment preferred.

Essential Knowledge, Skills & Abilities:

• Demonstrated ability to apply analytical methods.
• Demonstrated ability to work with all levels of Management.
• Demonstrated business acumen.
• Detail-oriented and self-motivated.

Significant Work Activities

N/A

Travel

No

Job Type

Experienced

Schedule

Full-time

Job Level Code

IC

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