Quality Lab Specialist

Essential Functions and Responsibilities

• C Conduct Quality Control Testing
• Execute a variety of chemical and physical analyses on raw materials, intermediates, and finished products to guarantee compliance with established quality standards.
• Utilize analytical instrumentation, including but not limited to HPLC (High Performance Liquid Chromatography), Gas Chromatography, Karl Fisher, Viscometer, Specific Gravity, and pH to perform quantitative and qualitative analyses.
• Perform method transfer and verification for new testing methods in the laboratory.
• Perform recovery studies and Total Organic Carbon (TOC) testing in support of cleaning validations.

Data Analysis and Troubleshooting

• Perform data analysis, identify trends, and troubleshoot issues, taking corrective actions as necessary.

Compliance and Approval Checks

• Ensure products meet specifications and conduct final product approval checks.
• Confirm label claims adhere to quality control specifications.

Documentation, Record-Keeping, and Quality Assessment

• Develop and gain approval on critical laboratory SOPs, Methods, forms and reports.
• Author, execute and gain approval on laboratory validation protocols.
• Maintain meticulous and precise records of all testing procedures, results, and any deviations from anticipated outcomes.
• Generate Certificates of Analysis (CoA) for each product batch, providing comprehensive documentation of quality specifications.
• Assess daily quality parameters and quality systems, covering cross-checks, raw materials, calibration, maintenance, procedures, training, auditing, and oversight of analytical testing.
• Document standard operating procedures and identify trends in testing results using data analysis from daily result entries.

Training and Support

• Train new quality chemists, and provide technical support to stakeholders, investigating quality problems and implementing actions to follow up.

Troubleshoot and Investigate

• Identify and investigate any discrepancies in quality standards, collaborating with production and relevant departments to promptly resolve issues.
• Utilize technical skills to lead or perform in-depth investigations for out of specification results and aberrant data.
• Draw conclusions and perform root cause analysis investigations and recommend solutions to prevent reoccurrence.

Continuous Improvement

• Participate in continuous improvement initiatives by suggesting and implementing enhancements to existing testing methods and processes.
• Establish and maintain a system to ensure proper supplies in the laboratory.
• Ability to train and mentor junior scientists.

Compliance and Safety

• Guarantee that all quality control activities adhere to industry regulations and safety standards.
• Contribute to maintaining a safe, clean, and orderly laboratory environment.
• Participate in internal/external audits as needed.

Other Duties

• Flexibly to work other shifts, and extended hours.
• Perform additional duties as assigned.