AbbVie

QA Associate, Data Reviewer

Employer
AbbVie
Location
Worcester, MA, United States
Posted
Feb 23, 2021
Ref
2102600
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 .

Description - External

Purpose:

Provides quality assurance support for projects, which may include, internal projects, and projects from contract manufacturing customers. This support may include, but is not limited to, the following areas: documentation support, batch record review, SOP review and revision, investigation of OOS materials and products, and participation in project team activities.

Responsibilities:

  • Review all production batch records for the manufacture of Humira, clinical manufacturing projects and contract manufacturing projects against specifications, and authorize release of materials or product.
  • Work as a liaison between the operating groups and the Document Control group to facilitate the identification, writing, reviewing, and approval of all documents to support a given project.
  • Ensure GMP and operational compliance with documentation related to the production of a batch or lot of material. This is accomplished through the systematic review of all the batch-related documents. Once all the documentation has been reviewed and signed off, assemble a batch disposition package which authorizes the approval or rejection of the given batch or lot.
  • Participate in project team meetings as representative for QA/Document Control group. Ensure overall GMP compliance with project through coordination of documentation, batch record review, and other means
  • Review and investigate exception reports for out of specification materials or products. Work with Production and Quality Control to investigate issues, determine causes, and identify and implement corrective actions.
  • Provide Quality Assurance support for a variety of projects at the site, including, but not limited to, process improvements, compliance for newly built manufacturing suites, better yields in production area, etc.
  • Interact with auditors from the FDA and/or contract manufacturing companies. Respond to auditor requests for files, documentation, records, reports, etc.
  • Contribute and adhere to safety, environmental, quality, and EEO/AA standards of the Corporation, Division, and Location.
  • Provide support on QA initiatives / special projects when necessary.
  • Work independently and release raw materials and components based on approved specifications
  • Use of discretion and independent judgment on final disposition of raw materials and component materials for use in manufacturing of biologics.


Qualifications

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

  • BS in a scientific discipline, or equivalent experience
    • 3+ years experience in a GMP-related field
    • Working knowledge of GMPs and their documentation
    • Experience with batch record review and working knowledge of batch release
    • Ability to work well in a project team environment
    • Good oral, written, and presentation skills
    • Strong computer skills utilizing a Microsoft environment (e.g. word, excel, access, PowerPoint)


Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.