Job Description

The Lead Quality Control Chemist will oversee and guide a team of chemists within the Quality Control laboratory of a dietary supplement manufacturing facility. This role involves developing, validating, and optimizing analytical methods for raw materials, intermediates, and finished products to ensure that all supplements meet rigorous quality and safety standards. The ideal candidate will have extensive experience in advanced analytical testing, addressing deviations, and ensuring compliance with FDA regulations and current Good Manufacturing Practices (cGMP).

Lead Quality Control Chemist Responsibilities:

• Supervise and mentor a team of chemists in the Quality Control laboratory.
• Manage daily laboratory operations, ensuring effective collaboration and high performance among team members.
• Develop, validate, and optimize analytical methods for raw materials, in-process materials, and finished dietary supplements.
• Perform analytical testing using techniques such as Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), and other relevant methods to verify product quality and compliance.
• Review and interpret test results to ensure accuracy and adherence to product specifications.
• Investigate and resolve deviations or out-of-specification results, implementing effective corrective and preventive actions.
• Ensure laboratory practices comply with FDA regulations, cGMP guidelines, and other applicable quality standards.
• Participate in internal and external audits by preparing and providing necessary documentation.
• Maintain laboratory equipment, ensuring calibration and proper maintenance.
• Optimize current testing methods to enhance efficiency, accuracy, and overall laboratory performance.
• Lead method development and validation studies to support product improvements and innovation.
• Manage laboratory relocation projects, including writing and reviewing performance qualification protocols for instrumentation.
• Evaluate change controls, conduct safety evaluations, and develop quality plans aligned with company policies and regulatory expectations.
• Collaborate with Research & Development, manufacturing, and regulatory teams to support product development and continuous process improvement.
• Stay up-to-date on industry advancements and regulatory changes that impact laboratory operations.

Lead Quality Control Chemist Requirements:

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Food Science, or a related field.
• Proven experience in a quality control laboratory environment, preferably within the dietary supplement or pharmaceutical industry.
• Demonstrated expertise in analytical testing techniques (e.g., GC, HPLC) and method development.
• Strong understanding of regulatory requirements including FDA regulations and current Good Manufacturing Practices (cGMP).
• Excellent analytical, problem-solving, and decision-making skills.
• Effective leadership and communication skills, with proven experience in managing laboratory teams.
• Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously.
• A commitment to continuous improvement and the optimization of laboratory processes.

Benefits:

• Above Market Compensation: Earn a competitive salary commensurate with experience.
• Health and Wellness: Access to comprehensive health, dental, and vision insurance plans to keep you and your family healthy.
• Retirement Savings: Participate in a robust 401(k) plan with employer matching contributions to help secure your financial future.
• Work-Life Balance: Enjoy generous paid time off, flexible scheduling options, and a supportive work environment.

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