Document Control/QA Analyst -Pharmaceutical Industry:
AbbVie

899164617
AbbVie
Campbell California
Pharmaceutical
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Description
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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. Allergan 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!

Analyst, Quality Assurance - 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 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."

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

  • Responsibility for managing and being the steward of a Document Control Center (DCC) for storage and archival of GMP documentation.
  • Integration, preparation and distribution and review of product documentation to support manufacturing operation consistent with corporate objectives and regulatory requirements.
  • Perform QA activities coordinated with manufacturing operations and Quality Control testing (review and approve raw materials, support facility shutdown and restart, etc.).

YOU WILL:
  • Be a trusted and expert partner. You will perform a key quality assurance role reporting to the Associate Director Quality. You will establish a Document Control Issuance process to issue and reconcile all GMP related paperwork. You will Identify and update appropriate procedures to assist in the management of QA system to ensure closure and approval. You will maintain physical and electronic files for both active and archived records of all relevant Quality Systems.
  • Build bridges. You will be responsible for implementing and coordinating quality systems including Training, Document Control Center 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. You will be responsible for establishing, implementing and the coordination of internal compliance audits response, corrective action plans and cGMP training. You will perform training on revised QA system SOPs.
  • Detailed quality master. You will be responsible for issuance and reconciliation of GMP paperwork such as Batch Record documentation, Quality Control test records, Notebooks, Logbooks and controlled forms.


Qualifications

YOU BRING:
  • BS degree in Biology, Biochemistry or a closely related science discipline
  • 2 to 3 years of QA systems experience within Biotech or Biopharmaceutical environment.
  • Experience in GMP documentation review is preferred.
  • Strong user of Track Wise, Microsoft Project, Excel.


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.
Basic Qualifications
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