Quality Control Chemist

Quality Control Chemist (Overnight Shift)

The Quality Control Chemist performs testing and evaluation of raw materials, bulk products, and finished goods in a GMP laboratory environment to ensure all products meet quality specifications and customer standards. This role focuses on accurate analytical testing, thorough documentation, troubleshooting out-of-specification results, and continuous improvement of laboratory processes. The position offers exposure to a wide variety of products, opportunities for growth into more complex methods and instrumentation, and an overnight schedule that requires a high degree of independence and responsibility.

Responsibilities

• Perform testing and evaluations of raw materials, bulk products, and finished products in accordance with written procedures and established test methods.
• Ensure current standard operating procedures (SOPs) and test procedures are followed and properly applied during all laboratory activities.
• Maintain accurate, complete, and compliant documentation records in alignment with GMP requirements and cGMP principles.
• Develop and maintain a strong understanding of various testing methodologies, including appropriate techniques, limitations, and potential sources of error.
• Keep laboratory notebooks, test records, and related documentation neat, legible, and organized at all times.
• Maintain clean, orderly, and well-organized work areas, including benches, equipment, and storage spaces.
• Verify that test results meet current product specifications and customer standards prior to completion or approval.
• Perform batch adjustments as needed during batch-making procedures to ensure products meet defined quality criteria.
• Troubleshoot out-of-specification (OOS) situations by investigating potential causes and working toward resolution.
• Ensure current reference standards and product standards are properly maintained, labeled, and used within their assigned validity.
• Update test procedures and product specifications as needed to reflect current requirements, methods, and best practices.
• Accurately record all analytical data and pertinent information in accordance with cGMP requirements.
• Document monthly Key Quality Incidents (KQIs) accurately and on time, ensuring trends and issues are clearly captured.
• Document OOS situations, determine root causes, and propose possible corrective and preventive actions.
• Maintain compliance with current regulatory expectations and practices, including relevant pharmacopeial standards such as USP.
• Utilize laboratory data to identify and drive improvement efforts so that customer requirements and regulatory regulations are consistently met.
• Support and promote a culture of lean action within the department by seeking ways to improve efficiency, reduce waste, and streamline processes.
• Use laboratory equipment such as pH meters, Brookfield spindle viscometers, and analytical balances accurately and safely.
• Perform visual and odor inspections of products and materials as part of routine quality evaluations.
• Adapt to changing priorities, business needs, and customer demands while maintaining high quality and productivity.
• Work independently during overnight shifts as the sole laboratory employee at the facility, while coordinating with counterparts and quality leadership at another site when needed.
• Participate in training and transition schedules, including daytime training and gradual shift changes, to ensure readiness for full overnight responsibilities.
• Support special projects or additional testing requirements that may arise due to increased customer volume or new product introductions.

Essential Skills

• 0–2 years of GMP laboratory experience, with a minimum of 6 months in a chemistry lab environment preferred (such as pharmaceutical, cosmetics, personal care, or food processing).
• Bachelor's degree in Chemistry, Biology, or a related science discipline preferred, or equivalent relevant experience.
• Hands-on laboratory experience with wet chemistry techniques.
• Experience using core laboratory instruments such as pH meters, Brookfield spindle viscometers, and analytical balances.
• Ability to perform visual and odor inspections as part of routine…