Essential Functions and Responsibilities:
C Conduct Quality Control Testing:
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Execute a variety of chemical and physical analyses on raw materials, intermediates, and finished products to guarantee compliance with established quality standards.
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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.
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Perform method transfer and verification for new testing methods in the laboratory.
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Perform recovery studies and Total Organic Carbon (TOC) testing in support of cleaning validations.
D Data Analysis and Troubleshooting:
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Perform data analysis, identify trends, and troubleshoot issues, taking corrective actions as necessary.
C Compliance and Approval Checks:
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Ensure products meet specifications and conduct final product approval checks.
- Confirm label claims adhere to quality control specifications.
D Documentation, Record-Keeping, and Quality Assessment:
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Develop and gain approval on critical laboratory SOPs, Methods, forms and reports.
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Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
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Author, execute and gain approval on laboratory validation protocols.
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Maintain meticulous and precise records of all testing procedures, results, and any deviations from anticipated outcomes.
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Generate Certificates of Analysis (CoA) for each product batch, providing comprehensive documentation of quality specifications.
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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.
T Training and Support:
- Train new quality chemists, and provide technical support to stakeholders, investigating quality problems and implementing actions to follow up.
T Troubleshoot and Investigate:
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Identify and investigate any discrepancies in quality standards, collaborating with production and relevant departments to promptly resolve issues.
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Utilize technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.
C Continuous Improvement:
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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.
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Ability to train and mentor junior scientists.
C Compliance and Safety:
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Guarantee that all quality control activities adhere to industry regulations and safety standards.
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Contribute to maintaining a safe, clean, and orderly laboratory environment.
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Participate in internal/external audits as needed.
Other duties:
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Flexibly to work other shifts, and extended hours.
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Perform additional duties as assigned.
