QC Analyst III

Katalyst Healthcares & Life Sciences

  • Portsmouth, NH
  • 30+ days ago

    Highlights

    The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activites. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.

    Numbers & Facts

    LocationPortsmouth, NH

    Description

    Job Description:
    The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activites. Also participate in quality testing for customer in-process, final product testing and stability studies when needed. Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
    Key Accountabilities:
    • Applies job skills and company's policies and procedures to complete a variety of tasks.
    • Running test samples for In-Process, Lot Release and Stability studies.
    • Running test samples for (but not limited to) investigations, transfers and validations.
    • Reviewing assays
    • Training others
    • Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
    • Projects such as method transfers, new instruments, method qualifications
    • Use of Microsoft Suites (Word, Excel, PowerPoint)
    • Use of Laboratory computer systems
    • Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
    • Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
    • Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
    • Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
    • Perform other duties as assigned.
    • Associate's Degree Microbiology, Biochemistry or Related Science Fields
    • Strong ability to speak publicly.
    • Strong ability to interpret data both alone and with guidance.
    • Perform assigned, complex and/or varied tasks.
    • Prioritization and problem solving.
    • Comprehend and follow instructions.
    • Direct, control and plan tasks/projects.
    • Brainstorming
    • Strong ability to communicate in both written and verbal format .
    • Exercises judgment within defined procedures and practices to determine appropriate action.
    • Self-motivated team player
    • Completes assignments on-time and accurately
    • Displays commitment to quality and performs job functions to the best of his/her ability
    • Relate to others in a team setting.
    • Maintain positive attitude in a team environment.
    • Timeliness in completing assigned tasks.
    • Works entire assigned shift, including arriving on time

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