Immunomedics, Inc.

Quality Assurance Associate, Raw Material Release and Clinical Shipments

US-NJ-Morris Plains
1 month ago
Job ID
2017-1029
# of Openings
1
Category
Scientific Manufacturing/Production

Overview

We are seeking a Quality Assurance Associate to be responsible for all QA-related aspects of material handling, storage, shipping and control, and associated documentation.  This position may also be cross-trained on product disposition and regulated document/training functions.

Responsibilities

  • Quarantine materials, inspect shipments, examine Certificates of Analysis (COAs), review test results, determine release status, and manage all raw materials documentation
  • Coordination of clinical shipments
  • Preparation and circulation of controlled documents (e.g., specifications, labels)
  • Inventory management
  • Stability data review
  • Generation of associated reports
  • Conduct changeovers in production area as required
  • Participate in audits, investigations, corrective action/preventive action (CAPA), standard operating procedure (SOP) preparation/revision/review, and other projects as appropriate
  • Participate in issue resolution and identify opportunities for process/system improvement

Qualifications

  • Bachelor’s degree in biology, chemistry, or related field, with 1-3 years of prior GxP experience in a Biotechnological, Pharmaceutical, or Clinical environment; or equivalent combination of education and experience 
  • Background/familiarity in raw material release and clinical shipments functions strongly preferred
  • Excellent written and verbal communication skills required; scientific writing experience a plus
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a fast-paced, timeline-driven environment necessary
  • Must be proficient with MS Office applications
  • Ideal candidate will possess a strong customer service philosophy 

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