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QC Reviewer Specialist II

Company: System One Holdings, LLC
Location: Piscataway
Posted on: March 30, 2024

Job Description:

Job Title: Quality Control Reviewer Specialist II

Location: Piscataway, NJ

Hours/Schedule: Mon-Fri, 8:30am-5pm

Type: Contract


  • Writes, revises, and reviews standard operating procedures (SOPs) and test methods.
  • Conduct reviews of release testing, stability testing, raw material testing, method validations, equipment qualifications and calibrations, technical protocols and reports to ensure compliance with internal procedures and policies, and cGMPs.
  • Provide assurance that documentation and testing comply with internal procedures, specifications, and cGMP regulations prior to generation of COA for product release.
  • Coordinates with lab analysts to resolve documentation or quality issues and implement corrective or preventive actions, as necessary.
  • Manages samples incoming and outgoing from laboratory, including reference standards.
  • Manages stability samples, including physical movement and documentation.
  • Performs or assists with lab audits.
  • Assists in the direction and training of other team members.
  • Coordinates projects and activities with other staff/departments, assures task completion, and supervises other team members, as necessary.
  • Has familiarity with FDA guidelines for biosimilars, USP, GLP, cGMP, Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines, ICH guidelines, and SOPs.
  • Assures that laboratory personnel are following all company SOPs and safety rules.
  • Prepares and revises technical documents (laboratory protocols, change control, OOS investigations, CAPAs, SOPs, etc.).
  • Assures that test batch records and deviations, OOS results, QA audits, and other paperwork are completed according to cGMPs and company SOPs.
  • Performs other functions as required or assigned.
  • Complies with all company policies and standards.

    • 3 to 4 years in cGMP pharmaceutical manufacturing environment is required.
    • Working knowledge of cGMP regulation is required.
    • In depth understanding and technical knowledge of the analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA performed under QC laboratory environment, and be familiar with all basic and some complex laboratory equipment/instrumentation.
    • Strong communication skills, both written and verbal.
    • Experience withreviewing release, stability, and raw material testing
    • Excellent organizational skills needed to perform or assist with Document Management activities, such as:
    • Identify and implement efficiency improvements to document control process
    • Sample management documentation
    • Stability sample management documentation, including adherence to test scheduling


      System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Keywords: System One Holdings, LLC, East Brunswick , QC Reviewer Specialist II, Other , Piscataway, New Jersey

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