AbbVie

*Senior Quality Assurance Analyst

Employer
AbbVie
Location
Irvine, CA, United States
Posted
Oct 03, 2020
Ref
202835
Required Education
Bachelors Degree
Position Type
Full time
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!

Senior Quality Assurance Analyst - 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 Senior Quality Assurance Analysts play an important role on our team and utilize their skills and abilities to contribute to world famous Biologics drugs"

This position performs as QA analyst in the area of quality assurance oversight of operations, production, process and equipment systems and validations at the Bioscience Laboratories Irvine facility.

YOU WILL:

Be a trusted and expert partner. You will be responsible for the quality assurance oversight of operational activities, production, and validations and Technical Services projects, ensuring that QA systems and manufacturing/engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration. Reviewing and approving as Quality Assurance site process and equipment validation documentation representative, including protocols, deviations, and final reports.

Build bridges. You will serve as the QA representative on validation and technical services projects.

Detailed quality master. You will support the change control activities associated with processes and equipment validations. You will manage the review/approval of DS development master batch records, executed batch records, manufacturing data, and validation and technical reports .

You will support the initiative in creating an embedded quality culture utilizing the following
  • Data driven decision making
  • Right First-Time initiatives
  • Failure Mode Effect Analysis
  • Risk Assessment and HACCP Principles
  • Contributing to BSL improvement initiatives
  • DSO requires that each Senior Analyst, Quality Assurance is proficient in multiple disciplines and areas including, Commercial life cycle phases at AbbVie sites, CMO and contract labs
  • AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements, and objectives.


Qualifications

YOU BRING:
  • BS degree in Biology, Chemistry, Biochemistry or a closely related discipline (or equivalent years of experience).
  • CQA is preferred
  • Minimum of five (5) years of QA experience within a pharmaceutical environment.
  • QC analytical experience is preferred
  • Prefer experience in a GMP regulated environment


ABBVIE LEADERSHIP SKILLS:
  • Excellence Focused
  • Boundaryless Mindset
  • Open and Authentic
  • Strategic Foresight

PDN2

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.