Sr Quality Assurance Analyst
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 specialist/analysts to work at our Campbell site in California. Be Bold and grow your manufacturing biopharmaceutical career with the pharmaceutical leader!
Senior Quality Analyst – Campbell, CA
“I’m looking for a team player in quality group with experience in GMP and Quality Systems. If you want an exciting opportunity supporting our organization to jump start your path to a successful career and contribute to keeping patients safe and healthy, I would be very interested in receiving your resume. Let’s discuss what you can bring to the team and what you aspire to do in the future.”
YOU ARE more than just a title, YOU ARE…
- An Initiator. You will be responsible to implement AbbVie policies and procedures at site as part of the Quality Systems Integration initiative.
- A Collaborator. The Senior QA Analyst will partner with other functional departments in areas of CAPA, Non-Conformance, Change Control, Routine Changes, Training, DCC and will supporting any DSO or Corporate driven initiatives to enhance these systems.
- Be a trusted and expert partner. Help site in ensuring we meet worldwide MOH cGMP regulatory requirements.
- Be Creative. Author changes to controlled documentation, including but not limited to operating procedures, work instructions, and forms. Create new or revise existing content with a high degree of quality.
- Act as SME for Non-conformance and Change Controls in Trackwise. Responsible for guiding the site for all steps in Trackwise to ensure timely completion of records.
- Coach/mentor and consult. Participate in project team meetings, working collaboratively with project team members from Manufacturing, Engineering, Facilities, Quality Control and other subject-matter experts to develop document content.
- Showcase attentive skills. Gathers information from SMEs, breaks complex processes into straightforward steps and ensures that procedures/documents contain the appropriate level of detail and instruction commensurate with the activity. Ensure that the information contained in procedures corresponds with the information on related documentation such as forms, inspection records, etc. including the appropriate verifications steps.
- Be an observant consultant. Ensure that technical information and parameters contained within operating procedures, work instructions and related forms match those parameters identified in associated validations and/or verifications.
- GMP Reviewer. Responsible for implementing and coordinating the QA review function ensuring all quality documents including batch records, QC records, and Validation documents, are reviewed in a timely manner. The review function will also be responsible for generation of APR’s, QA reports, and stability reports.
- BS degree in Biology, Biochemistry or a closely related science discipline.
- 4-7 years in Biotech or Biopharmaceutical
- Understanding of US/EU cGMP regulations
- Experience with Regulatory and Internal Inspections.
- In depth knowledge of document authoring tools, including MS Office Suite, TrackWise and One Vault
- Excellent oral and written communication skills as well as strong organizational skills.
- Interpret and evaluate data and summarize results.
For this role, we’re looking for a leader who is:
- Excellence Focused
- Open and Authentic
- Boundaryless Mindset
Significant Work Activities
Continuous standing 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.