Senior QC Analyst - Chemistry

Overview

• CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions driven team members with a flexible approach, who want to be part of the company’s continued success.

• Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis; and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.

• We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS.

The Role

• The QC Senior Analyst position serves as a subject matter expert in the QC Laboratory. This position directs and performs analytical methods for complex testing on raw materials, in process samples, stability, and finished products. Supports internal development and/or manufacturing operations. The QC Senior Analyst makes detailed observations and analyzes, resolves issues, documents, and communicates test results. The QC Senior Analyst executes and validates test methods for raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, and traditional quantitative analysis utilizing HPLC, GC, and/or traditional wet chemical testing. In addition, this position is responsible for providing support for environmental testing, validation, stability and other various laboratory and production testing as needed.

Key Responsibilities

• Lead training of all new employees and maintain all training documentation via current system

• Support the OOS system Laboratory Investigations, and assist in any related CAPAs, deviations, etc

• Perform advanced chemical testing using analytical instrumentation including HPLC, GC, FTIR, UV-VIS, etc.

• Provide help with troubleshooting of analytical instrumentation and advanced maintenance

• Provide a mentoring relationship for QC Analyst I and II

• Facilitate QC audit readiness with understanding of FDA and ISO regulations and requirements

• Support on-time performance in the QC lab against the Production and laboratory schedules

• Maintain a safe, clean, and organized environment (5S) for all QC areas.

• Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal and customer requirements.

• Assist in writing and revising SOPs and WIs to ensure cGMP compliance.

• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices

• Any additional functions as assigned by the Laboratory Manager

Who You Are

• B.S. in Chemistry or related scientific field 4+ years related experience or M.S. in Chemistry or related scientific field 2+ years related experience

Where You Come From

• Excellent proficiency with HPLC, GC, KF, FTIR, and other wet chemistry methodology

• Experience working in an ISO or FDA regulated environment

• Expertise with Empower

• Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions, and write clearly and informatively.

• Ability to problem solve and make decisions that are GMP compliant.

• Ability to read and execute compendia methods from USP

• Proficiency with Microsoft Word, Excel, and Access.