Immunomedics, Inc.

Quality Assurance Specialist II (On the Floor) -W-Sat shift

Job Locations US-NJ-Morris Plains
Posted Date 5 months ago(2/13/2020 1:28 PM)
Job ID
2020-1612
# of Openings
1
Category
Quality

Overview

Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, as required. Perform Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required.  This individual manages the batch documentation package and maintains records.  Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Responsibilities

  • Provides oversight to operations on the shop floor as required. Supports manufacturing operations (upstream and downstream) at real time.
  • Reviews production batch documentation package for batch release as required.
  • Communicates release status to appropriate personnel.
  • Maintains appropriate records.
  • Maintains and supports material inventory, status and transfers.
  • Performs and supports changeovers in production area as required.
  • Prepares Certificates of Analysis (COAs).
  • Assists in preparing Annual Reports as required.
  • Revises SOPs as required.
  • Participates in audits and other projects as appropriate.
  • Performs routine manufacturing batch production record review in support of product batch release in accordance with specifications and SOPs.
  • Supports manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise.
  • Reviews documentation associated with production operations. Ensures adequate levels of documentation are acceptable and compliant to existing procedures.
  • Reviews and audits production batch records to ensure adherence to Immunomedics policies, SOPs, and cGMP requirements.
  • Supports and performs Raw Material Disposition as required.
  • Supports and performs Clinical Shipments as required.
  • Initiates deviation reports and participate in activities for issue resolution.
  • Participates in process improvement initiatives targeting for Right First Time (RFT) on documentation.
  • Participates in writing investigations.
  • Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings.
  • Implements and ensures adherence of appropriate regulations and Immunomedics quality standards.
  • Writes, reviews and approves Standard Operating Procedures (SOPs), as needed
  • Supports operations to encourage a Quality Culture and ensure a safe working environment.
  • Provides training to QA personnel where appropriate.
  • Completes job-related training as required.

Qualifications

  • BS/BA in Biological Sciences or equivalent relevant career experience.
  • 3-5 years of experience in a Pharmaceuticals environment.
  • Practice knowledge and understanding of cGMPs.
  • Biologics manufacturing experience or knowledge a plus.
  • Excellent written and verbal communication skills required, including Responsible Business Communication.
  • 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.

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