Independently performs routine and non-routine testing. Performs laboratory testing within a GMP environment in support of one or more of the following areas; raw materials, in-process product, final Bulk product, stability, and/or validation. Analyzes test data, evaluates results and forms conclusions with minimal outside input. Is able to recognize laboratory technique or instrumental events that could impact the integrity of the test data. Recognizes and resolves simple to moderately complex technical problems. Writes procedures with minimal guidance. Works under the general guidance of a supervisor but can effectively manage their own time to ensure timely completion of assigned duties. Trends data to support assay performance. Effectively writes all types of exception
reports.

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.