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Quality Assurance Specialist

Expired Job

Immunomedics, Inc. Morris Plains , NJ 07950

Posted 2 months ago

Overview

Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, and other GMP processes as required. 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. Support manufacturing operations (upstream and downstream) at real time.

  • Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.

  • Support 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.

  • Review and audit production batch records to ensure adherence to Immunomedics policies, SOPs, and cGMP requirements.

  • Provide support to QA Batch Release to assist with batch record release and compliance issues.

  • Initiate deviation reports and participate in activities for issue resolution.

  • Participate in process improvement initiatives targeting for Right First Time (RFT) on documentation.

  • 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.

  • Write, review and approve Standard Operating Procedures (SOPs), as needed

  • Support operations to encourage a Quality Culture and ensure a safe working environment.

  • Complete job-related training as required.

Qualifications

  • BS/BA in Biological Sciences or equivalent relevant career experience.

  • 3 + years of experience in a Pharmaceuticals environment.

  • Practice knowledge and understanding of cGMPs.

  • 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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Quality Assurance Specialist

Expired Job

Immunomedics, Inc.