QC Technical Transfer Analyst

Job Description

Quality Control Technical Transfer Analyst 3

Position Summary

The Quality Control Technical Transfer Analyst (QC Analyst III) will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. 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 Responsibilities

• Testing and Analysis
• 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.
• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Documentation and Compliance
• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods.
• Use of Microsoft Suites (Word, Excel, PowerPoint).
• Use of Laboratory computer systems.
• Potential previous use of GMP Quality Systems such as : TrackWise, LIMS.
• Apply Data Integrity principles in all aspects of work, in compliance with DI policies, guidelines and procedures.
• Technical Transfer and Training
• Projects - such as method transfers, new instruments, method qualifications.
• Training others.
• 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.
• Perform other duties as assigned.

Minimum Requirements

Education

Skills And Qualifications

Preferred skills : A280, CE-SDS, icIEF, ELISA, SoloVPE, qPCR.

Seniority level

Employment type

Job function

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