Sr. Quality Control 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.

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!

Senior Quality Control Analyst – Irvine, CA

What your manager wants you to know:

“I am looking for a team player with strong QC lab experience in a cGMP environment.  If you are motivated, organized, have strong communication and written skills, I would be very interested in receiving your resume.  Let's discuss what you can bring to the team.”

Successful senior quality control analyst candidates will contribute by: providing analytical support for the manufacture, release, and stability testing of GMP drug substance produced at AbbVie DSO.

YOU WILL:

Be the trusted and expert partner in the lab.   You are the QC expert regarding the technical principles, theories, concepts and best practices of the analytical techniques used in the chemical analysis of drug substances and raw materials in the DSO organization. You apply your expertise to provide input when troubleshooting difficult issues.

Detailed compliance master.   You research and understand source regulatory documents to provide input into the development of processes and procedures used in the QC department. You are highly proficient at GMP documentation and will serve as the advisor to junior peers on GMP documentation practices

Build bridges.    You have the knowledge of the techniques used in the QC department and have an understanding of how results impact the quality of the drug substances manufactured at DSO.  You will collaborate frequently with departments in the conduct of day to day operations including special projects.  You will represent the QC department on cross functional teams, both within and outside DSO.  You will communicate effectively with regulatory inspectors and you will act as the AbbVie representative to contract entities.  You will ensure that the analysis in contract entities is conducted to AbbVie standards of quality.

Qualifications

YOU BRING:

• Bachelor’s degree in biology or chemistry strongly preferred.  
• Minimum of five years experience in the lab in chemistry in a GMP pharmaceutical manufacturing and/or development environment. 
• Strong HPLC and GC skills.
• Industry experience in chromatography data collection/processing software. Empower preferred.
• Industry experience in GMP documentation and working in a GMP environment with gowning and respirators. 
• In-depth knowledge in mammalian cell culture techniques preferred
• Hands-on practice in 96-well format of bioassays preferred
• Familiar with basic instrumentation associated with bioassays, examples include but not limit to luminescence, fluorescence and colorimetric 96-well plate readers, centrifuges, plate washer, cell imager, microscope preferred
• Proficiency in statistical software such as JMP, MiniTab, Gen5 and SoftMax Pro preferred
• Experiences in assay automation is a plus

ABBVIE LEADERSHIP SKILLS:

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

Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.