QC Analyst III

Job Type

Full-time

Description

Position Summary

The QC Analyst III will be responsible for analytical testing and data verification / review supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.

Essential Duties & Responsibilities

• Analytical testing to support product in-process, release, and stability programs.
• Perform the data verification / Review process as assigned.
• Participate in Method Validation activity.
• Preparation of the Protocols / Reports as assigned.
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Conduct, compile, and / or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
• Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.
• Performs other functions as required or assigned
• Complies with all company policies and standards
• Preparation and routing the change control documents as required.

Requirements

Position Requirements and Qualifications

Education :

Experience :

Specialized Knowledge and Skills :

Work Environment & Physical Demands :

General Working Environment :

Noise :

Standing / Lifting :

Visual :

Stress :

Travel :

Supervisory Responsibility, if any : No

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.