Immunomedics, Inc.

Quality Assurance Associate, Product Disposition

US-NJ-Morris Plains
1 month ago
Job ID
2017-1030
# of Openings
1
Category
Scientific Manufacturing/Production

Overview

We are seeking a Quality Assurance Associate to be responsible for the Product Disposition function, encompassing the review of production batch records and associated documentation required to release a production lot.  This individual manages the batch documentation package and maintains records.  This position may also be cross-trained on the Raw Material Release/Clinical Shipments and Regulated Document/Training functions.

Responsibilities

  • Review production batch documentation package for lot release. 
  • Communicate release status to appropriate personnel. 
  • Prepare, revise, and maintain Certificates of Analysis (COAs).
  • Maintain controlled records.
  • Review Process Simulation (media fill) system as required.
  • Conduct changeovers in production area as required. 
  • Inventory management.
  • Stability Data Review.
  • 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 product disposition, batch record review, and/or raw material release strongly preferred.
  • Excellent written and verbal communication skills required, including Responsible Business Communication; scientific writing experience a plus.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Must be proficient with MS Office applications.
  • Ideal candidate will possess a strong customer service philosophy. 

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