Quality Assurance Analyst

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 .

Job Description

Envision working with energetic colleagues and inspirational leaders. AbbVie is always striving to find top scientists to work at our Irvine, CA site. Be Bold and grow your manufacturing biopharmaceutical career with the pharmaceutical and medical device industry leader!

Analyst, Quality Assurance - Irvine, CA

What your manager wants you to know:

" I'm looking for a team player with experience in a fast-paced Quality Operations Environment. Our Quality Assurance Analysts play an important role on our team and utilize their skills and abilities to produce world famous Biologics drugs. If you want to jump start your path to a successful career and contribute to keeping patients safe, healthy, and happy, I would be very interested in receiving your resume. Let's discuss this exciting opportunity and your goals for the future. Be Bold!"

YOU WILL:

Be a trusted and expert partner . You will perform quality assurance oversight of operational activities, production, validations and technical services projects and documents. You will ensure operations and validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing internal and external audits of our processes. You will serve as the QA representative on validation and technical services projects.

Build bridges. Serving as the QA contact with all vested parties including QA/QC laboratories, IS, Manufacturing, and Engineering relating to process and equipment validations. You will maintain a clean and organized work area. You will assist AbbVie in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.

Detailed quality master. You will perform review of laboratory data and manufacturing batch records. You will provide QA Support for change control activities associated with processes and equipment validations. You will perform all assigned duties according to departmental SOP's and cGMP's. You will remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department.

Qualifications

YOU BRING:

• Minimum B.S. in Biology, Chemistry, Biochemistry or a closely related discipline from an accredited institution
• Minimum of three (3) years of experience in a pharmaceutical environment with a minimum of one (1) year working in a quality related department. A Master's degree may substitute for two years of experience.
• Experience in a GMP regulated environment required, experience in GMP documentation review is preferred
• Strong user of Track Wise, Microsoft Project, Excel

ABBVIE LEADERSHIP SKILLS:

• Excellence Focused
• Boundaryless Mindset
• Open and Authentic
• Strategic Foresight

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.