QUALITY CONTROL PRINCIPAL CHEMIST

Job Description

Job Description

Position Summary

The Principal Chemist is a senior lab position providing advanced technical expertise for routine and non-routine analytical and physical tests on raw materials and OTC drug / medical device / cosmetic personal care products. Tasks also include research, development, and implementation of new analytical test methods and performing method validation & verification studies.

This position requires an experienced professional with advanced knowledge of Analytical equipment usage, strong multitasking abilities, a fast-paced work ethic, excellent problem-solving skills, and a positive attitude while working in a team-oriented cGMP environment.

This position requires the ability to carry out tests and complete tasks with a high degree of accuracy, an advanced level of judgement, and independent thinking. Serves as a technical resource and mentor to less experienced Chemists and Technicians.

Essential Duties and Responsibilities

• Perform testing using analytical techniques, instruments, and methodology including but not limited to HPLC, ICP-OES, and FTIR analysis, Viscosity, pH, Specific Gravity, and other laboratory analysis
• Operate, maintain, troubleshoot, and calibrate analytical equipment and related software including HPLC and ICP-OES systems.
• Prepare standards, reagents, and samples.
• Review and interpret analytical data to ensure compliance with specifications and regulatory requirements. Prepare reports and preform trend analysis as needed.
• Maintain accurate and complete laboratory documentation and records in Goodier documentation systems including, but not limited to, electronic lab notebooks, LIMS, and manual systems in compliance with cGMP, FDA, and company requirements.
• Develop, optimize, and validate methods, facilitate effective method transfers, and design & perform method verification studies.
• Lead / support Out of Specification (OOS) investigations, deviations, CAPAs, and laboratory investigation processes.
• Create, revise, and review lab methods, SOPs, specifications, technical documents, and data reports.
• Provide subject matter expert support to troubleshoot instrumentation, method, and testing issues.
• Serve as a technical authority on analytical chemistry matters, providing clear, concise data and interpretation related to non-compliant, atypical, or out-of-specification lab results to operational teams and senior leadership.
• Support / coordinate lab equipment maintenance, preventative maintenance, and calibration activities to ensure proper function and compliance.
• Ensure laboratory organization, cleanliness, and compliance with safety procedures.
• Order and maintain lab supplies, standards, and inventory.
• Train and mentor junior chemists and technicians.
• May perform laboratory technician and/or Supervisory functions as needed.
• Collaborate effectively with Production, Quality Assurance, R&D, Supply Chain, and other departments.
• Perform additional duties as assigned.

Qualification Requirements

• Bachelor’s Degree in Chemistry or related scientific field required.
• Minimum of 8 years of analytical laboratory or directly related experience in the personal care, cosmetic, pharmaceutical, or other cGMP-regulated industry.
• Advanced level knowledge and relevant working experience with analytical instrumentation and equipment including HPLC, ICP, FTIR, Water Activity Meter, Viscometer, pH meter, and other lab instrumentation and equipment. Familiarity with GC / GC-MS techniques and instrumentation is a plus.
• Accurately prepare samples by applying wet chemistry techniques, operate advanced analytical chemistry equipment, and perform complex testing under general guidance. Experience with USP methods strongly preferred.
• Experience with Empower, Qtegra, or similar laboratory software systems preferred.
• Strong troubleshooting, analytical, and problem-solving skills are required.
• Exceptional attention to detail and ability to work with a very high degree of accuracy and integrity.
• Must be self-motivated and have the ability to work quickly and efficiently in a fast-paced environment handling multiple projects and priorities simultaneously while maintaining accuracy and data integrity.
• Excellent multitasking and time-management skills to prioritize workload effectively.
• Positive attitude, strong work ethic, and ability to work well in a team-oriented environment. Willingness to guide and train junior colleagues.
• Excellent verbal and written communication skills. Ability to clearly communicate analytical findings to cross-functional teams and leadership that may not have chemistry expertise.
• Able to perform mathematical calculations.
• Thorough knowledge of cGMP, GLP, and GDP requirements.
• Proficiency with Microsoft Office programs (Outlook, Excel, Word, Teams), electronic laboratory notebooks, and Laboratory Information Management Systems (LIMS).
• Ability to work on site at Goodier Labs.

Physical Requirements

• Ability to stand for extended periods of time.
• Ability to lift laboratory materials and supplies up to 25 lbs.
• Ability to work safely with chemicals and laboratory equipment following all safety procedures.