Quality Assurance Project Specialist

Waukegan, IL

Post Date: 07/27/2017 Job ID: 22919 Category: Professional

Job Description:
  • LinkUs is a relational database that is currently being used to capture the knowledge generated during the small molecule Product Transfer Process.
  • They will help to translate technical documents on drug substance (DS) and drug product (DP) manufacturing and enter the relevant information.

Source documents include, but are not limited to:

  • Process Control Justification (PCJ), Process Development Reports (PDRs), Risk Assessment Memos, process Failure Modes and Effects Analysis (FMEAs), Exception Reports, Batch Records, Correction and Preventative Actions (CAPAs) and Development Modifications.

  • Strong science and/or technical background.
  • Technical understanding of manufacturing, especially pharmaceutical manufacturing.
  • Basic understanding of Quality Risk Management.
  • Computer literacy and an ability to become proficient with new computer software.
  • Strong collaborator, sharing information freely.
  • Good verbal and written communication skills.
  • A strong understanding of 5 Why s to facilitate connecting why something happens to cause.
  • Demonstrated record of problem solving, relentless curiosity.
  • Focus on continual improvement.

Key Competencies:
  • Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
  • Learns fast, grasps the "essence" and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Prefer bachelor s degree.

A-Line Staffing Solutions



Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: