Sign upLog in
See more jobs

QC Technical Transfer Specialist

Katalyst Healthcares & Life Sciences

  • Portsmouth, NH
  • 30+ days ago

    Highlights

    The Quality Control Analyst supports laboratory operations by performing analytical testing, reviewing laboratory data, supporting method transfers and validation activities, and ensuring compliance with GMP and Data Integrity requirements. This role works within a pharmaceutical or biotechnology quality control laboratory and collaborates with cross-functional teams to support product quality and regulatory compliance.

    Numbers & Facts

    LocationPortsmouth, NH

    Description

    Job Summary
    The Quality Control Analyst supports laboratory operations by performing analytical testing, reviewing laboratory data, supporting method transfers and validation activities, and ensuring compliance with GMP and Data Integrity requirements. This role works within a pharmaceutical or biotechnology quality control laboratory and collaborates with cross-functional teams to support product quality and regulatory compliance.

    Responsibilities
    • Perform analytical testing for raw materials, in-process samples, finished products, stability samples, and lot release testing.
    • Execute analytical methods following GMP guidelines.
    • Support analytical method transfers between laboratories.
    • Assist in method validation and verification activities.
    • Review laboratory data for accuracy and completeness.
    • Investigate laboratory deviations and Out-of-Specification (OOS) results.
    • Prepare and maintain GMP documentation.
    • Support Change Controls, CAPAs, Deviations, and Investigations.
    • Perform root cause analysis and implement corrective actions.
    • Maintain laboratory instruments and equipment.
    • Utilize laboratory software including LIMS, Empower, SoftMax Pro, SoloVPE, and TrackWise.
    • Support software validation and CSV activities.
    • Ensure compliance with cGMP, GDP, ALCOA+, and Data Integrity principles.
    • Participate in audits and inspection readiness.
    • Collaborate with QA, Manufacturing, Validation, and Engineering teams.
    • Train laboratory personnel on procedures and systems when required.

    Similar Jobs