Sr Quality Control Analyst - Chemistry
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.
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Senior Quality Control Analyst – Campbell, CA
WHAT YOUR NEW 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: performing the laboratory tests for API release and stability testing. You will perform raw material testing and review raw data and certificate of analysis for raw materials, in-process test data, and final product test results, ensuring that all testing is performed according to the FDA, Foreign MOH and AbbVie requirements.
- Be the trusted and expert partner in the lab. Train staff in the areas of QC testing, compliance, and documentation preparation. Conduct lab investigation. Organize daily lab routine duties include daily performance of all activities pertaining to the lab.
- Detailed compliance master. Responsible for writing, reviewing testing procedures, and streamlining to increase lab efficiency. Writing and reviewing the QC procedures, receiving equipment and contacting the outside contract laboratory.
- Build bridges. Serve as a technical resource representing QC during FDA and Ministry of Health inspections through minimum supervision you can respond to manager’s suggestions to effectively plan, organize and implement tasks. You will support performance qualification, validation studies and routine validation requirements for QC equipment. You will write URS and Risk Assessment for QC equipment purchase as needed. You will lead and participate in continuous improvement activities within the Drug Substance Operations (DSO). Prioritize duties in a manner consistent with management objectives. Share ideas and tasks towards achieving team success
- Bachelor’s degree
- 5 or more years of QC lab experience with protein experience in Biotech or Pharmaceutical environment is highly desired.
- Expert proficiency in lab area testing methodology and demonstrated expertise in QC laboratory operations.
- Strong user of the Empower, Chemstation, LIMS, Excel, and PowerPoint.
- A thorough understanding of cGMP regulations and experiences in regulatory inspection is required.
- Technical skills including HPLC, GC, qPCR, TOC, gels, as well as traditional chemistry. Familiarity with USP, EP, JP, and CP pharmacopoeia.
ABBVIE LEADERSHIP SKILLS:
- Excellence Focused
- Boundaryless Mindset
- Open and Authentic
- Strategic Foresight
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.