AbbVie

*Senior QA Analyst

Employer
AbbVie
Location
Campbell, CA, United States
Posted
Sep 24, 2020
Ref
202982
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 Campbell, CA site. Be Bold and grow your manufacturing biopharmaceutical career with the pharmaceutical and medical device industry leader!

Senior Quality Assurance Analyst - Campbell, 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 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!"

Successful senior quality assurance analyst candidates will have the following types of experience:

This is a key quality assurance role reporting to the Associate Director Quality Bioscience Laboratories (BSL), Campbell. This position performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation at the BSL, Campbell facility.

YOU WILL:

Be a trusted and expert partner. 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.

Build bridges. Responsible for implementing and coordinating quality systems including CAPA, deviation, change control, work order systems, Training, DCC and supporting any DSO or Corporate driven initiatives to enhance these systems, this position will be a delegate for the Associate Director Quality in assessing and approving quality system documentation.

Detailed quality master. Responsible for implementing and coordinating all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation. Identify and update appropriate procedures to assist in the management of QA system to ensure closure and approval. Integration, preparation and distribution and review of product documentation, master batch records, media holds etc. to support operations and quality control departments consistent with corporate objective, GMP, and regulatory requirements.

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
  • BSL 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, Biochemistry or a closely related science discipline.
  • CQA or equivalent
  • 4 to 7 years of QA systems experience within Biotech or Biopharmaceutical environment
  • Strong user of Quality Management Systems like Trackwise
  • A thorough understanding of US/MOH cGMP and GLP regulations, and experiences in regulatory inspection is required
  • 5 to 10 years of Direct experience within Biotech or Biopharmaceutical environment


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.