Chemist

Position: Chemist 2
Job Title:

Analytical Chemist IIJob Description

The Analytical Chemist II plays a key role in ensuring that raw materials, bulk products, and finished goods meet all customer and regulatory analytical requirements. This salaried position is part of the quality team and focuses on method validation, data integrity, and compliance within a cGMP laboratory environment. The role supports the growth and success of customers by delivering accurate, timely, and compliant analytical testing for cosmetic and household products.

Responsibilities

+ Validate laboratory procedures, processes, test methods, chemical assays, and equipment used to detect and identify active ingredients to ensure compliance with customer and regulatory guidelines.

+ Develop, validate, and optimize analytical test methods to ensure compliant methods are used for testing controlled articles, including raw materials, bulk, and filled product.

+ Calibrate, monitor, and maintain analytical test equipment such as HPLC and GC systems to ensure reliable performance and accurate results.

+ Accurately record all data and pertinent information in accordance with cGMP requirements, maintaining complete and traceable documentation.

+ Create monthly Key Quality Indicators (KQI) promptly and accurately to support quality monitoring and continuous improvement efforts.

+ Conduct batch record reviews to determine compliance with cGMP practices and identify any deviations or gaps.

+ Document out-of-specification (OOS) situations, determine root causes, and propose potential corrective and preventive actions (CAPA).

+ Lead OOS investigations, review findings, and approve analytical data package reports (ADPRs) for filled product and stability studies.

+ Ensure analytical specifications are met for all tested materials and that results are documented, maintained, and communicated to meet customer expectations.

+ Report test results and manage the accurate and timely release or transition of quarantined raw materials, bulk product, and finished products based on analytical findings.

+ Troubleshoot out-of-specification results and analytical issues, providing technical guidance and solutions to restore compliance.

+ Ensure Good Laboratory Practices (GLP) are followed and that all activities comply with applicable regulatory guidelines.

+ Maintain laboratory notebooks in a complete, accurate, and up-to-date manner to support traceability and audit readiness.

+ Participate in internal and external audits, providing documentation, explanations, and support for laboratory and quality activities.

+ Institutionalize 5S practices (Sort, Straighten, Shine, Standardize, Sustain) in all aspects of the department to promote organization, efficiency, and safety.

+ Serve as a senior technical resource within the lab, providing mentorship, training, work review, troubleshooting support, and QC assistance to other chemists.

+ Collaborate closely with Analytical Chemists I & II and QC Chemists in a team-based environment to meet production and quality goals.

+ Adapt to changing priorities and workloads while maintaining high standards of quality, safety, and regulatory compliance in a fast-paced, high-volume setting.

Essential Skills

+ Bachelor's degree in Chemistry or a related scientific discipline.

+ 2+ years of industry analytical chemistry experience, including hands-on work with HPLC, GC, and USP methods.

+ 2+ years of experience with analytical method development or optimization.

+ Working knowledge of Empower software for chromatographic data acquisition and analysis.

+ Demonstrated experience in a cGMP laboratory environment, including adherence to cGMP documentation and data integrity standards.

+ Strong analytical chemistry skills, including wet chemistry techniques and quantitative analysis.

+ Proficiency in gas chromatography (GC) and high-performance liquid chromatography (HPLC).

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Experience with method development and method validation protocols in a QC or analytical setting.

+ Effective problem-solving skills with the ability to troubleshoot analytical and equipment-related issues.

+ Ability to work effectively in a high-volume, fast-paced environment while maintaining…