Quality Control Associate II

Employer
AbbVie
Location
Lake County, IL, US
Posted
Aug 13, 2019
Ref
1905513
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
  • Must be familiar with ICH and GCP Guidelines.
  • Must demonstrate good interpersonal and organizational communication skills.
  • Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
  • Conducts independent quality review of documents by checking against source (documents and/or data) to ensure that the results presented are accurate (emphasis on checking the numbers/data in the text and in-text tables against the final statistical tables, listings, and graphs (TLGs). Deliver documented quality review comments/checklist to document author through resolution.
  • Ensures QC review documentation from all applicable functional areas is completed and provided to Document Management for the TMF per the established business processes and procedures.
  • Maintains strong knowledge of clinical regulatory documents requiring QC as well as business processes and procedures for these documents. Demonstrates strong attention to detail and a high level of quality, consistency, and accuracy in work effort.
  • Daily interaction with Medical Writers and/or Medical Writing managers as well as interface/communication with applicable cross-functional areas. Communicates and provides deliverables to Medical Writers, Medical Writing managers, and others as applicable
  • Mentors and provides guidance/training to less senior Medical Writing staff or others as applicable. Back-up to individual maintaining overall QC schedule and the assignment of QC review of clinical regulatory documents.
  • Accountable for meeting the main objectives of the assigned projects/roles and responsibilities within established timelines and with an appropriate quality level. Drives the QC of clinical regulatory documents to timely completion.
  • Accountable to Senior Manager, Medical Writing. Exhibits a moderate level of technical competencies and requires a low level of counsel and guidance. Expedient escalation of issues to management is essential and may have a direct impact on the ability to meet project timelines.


  • Bachelor's degree (BA/BS) required.
  • 2-4 years relevant pharmaceutical industry experience in medical writing, clinical research, quality, or related area such as regulatory or product support.
  • Experience in quality review of clinical regulatory documents.
  • Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
  • Proficient experience in use of MS Office (e.g., Word, Excel, Outlook, PowerPoint) and Adobe Acrobat. Experience/familiarity with SharePoint, ISIPublisher, and eDocs (i.e. electronic document management system) desirable.
  • Project management experience desired.