Scientist, Quality Control

Role Summary

Scientist, Quality Control conducts routine and non-routine testing in a GMP environment, analyzes data, and supports assay performance across materials, in-process, final product, stability, and validation areas. The role involves writing procedures with minimal guidance, managing time effectively, and contributing to process improvements and investigations.

Responsibilities

• Performs more complex test methods as written to support product/material release with minimal error.
• Understands laboratory techniques and principles performed.
• Interprets experimental data for conformance with product/material specifications.
• Understands, implements and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Assists with writing and performs validation assays per approved protocols.
• Can effectively perform a multitude of laboratory techniques for which they are trained on with minimal error.
• Make recommendations for process improvement.
• Writes/revises procedures as necessary and provides support for department.
• Develops and maintains trend reports, backlog report, and document error reports which support departmental performance.
• Authors all types of Investigations and deviations effectively. Assist in troubleshooting assays.

Qualifications

• BA/BS in Chemistry, Biochemistry, Medical Technology, Biology or equivalent science degree.
• 5-8 years of related work experience
• Maintains their certifications as needed for assigned job tasks.