Immunomedics, Inc.

  • QC Analyst

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(12/11/2018 11:46 AM)
    Job ID
    2018-1381
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    The QC analyst is responsible for release testing of incoming raw materials and utilities (water and gas) samples testing. The incumbent will be supporting testing and method validation activities either inhouse or at a third-party provider. The responsibilities may also include receiving, inspection and sampling of incoming raw materials as assigned. This position also includes responsibility for authoring technical reports, specifications for incoming raw materials and evaluation of change notifications, as directed

    Responsibilities

    • Works in a cGMP QC laboratory setting, responsible for utility testing and raw material testing in house and supports testing at a third-party provider (TPP). Executes routine wet chemistry testing following SOPs and records data in a GMP compliant manner
    • Ensures timely delivery of test results to meet deadlines for release of raw materials, and process intermediates. Accountable for maintenance performance of instrumentation and documenting any routine or preventative maintenance in the system.
    • Manages raw material retains, supports inventory management, collects utility samples using established procedures as part of environmental monitoring.
    • Effectively participates in validation and technical transfer of analytical methods in compliance with FDA, compendia and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports.
    • Participates in implementation of spectroscopy-based identity testing for incoming raw materials and other analytical method development activities, both inhouse and at TPP.
    • Perform preventative maintenance and/or calibration activities or coordinate and schedules these activities with a third-party provider.
    • Responsible for cleanliness and orderliness of work area, maintains the laboratory in a state of inspection readiness and performs other laboratory maintenance duties as assigned.
    • Participates in QC continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
    • Individual may be called upon to perform additional tasks as assigned by supervisor.
    • Maintains required training and training records and provides training to qualify other Laboratory Associates.

    Qualifications

    • Requires BS Degree in chemistry, biology, or related discipline, with 1-3 years’ experience. Prior experience of incoming raw material testing in pharmaceutical/ biotechnology industry in a cGMP environment is required.
    • Experience with aseptic techniques and microbiological assays is an advantage.
    • Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines
    • Ability to work in a highly regulated (commercial GMP) team environment and perform job responsibilities under minimal supervision
    • Working knowledge of analytical methods for raw material testing, compendial affairs, wet chemistry, spectroscopic methods, utility testing.
    • Attention to detail in documentation, good organizational and time management skills.
    • Some experience with development, transfer and implementation of analytical method validation based on FDA and ICH guidelines is a plus. Prior experience with microbiological testing and aseptic techniques is also a plus but not required.

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