QC Technician III
Charlotte, NC, US
Scientific
Bachelors Degree
Full Time, Direct Hire
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Charlotte, NC, US
Experienced (Non-Manager)
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Job Title: Quality Control Technician III (Chemistry / HPLC Focus)
Location: Charlotte NC
Hourly Pay Rate: $32
Job Summary:
The Quality Control Technician III plays a key role in ensuring the quality and consistency of chemical products through rigorous testing of production batches and raw materials, with a strong emphasis on HPLC analysis. This role involves independently executing complex analytical methods, interpreting chromatographic data, and contributing to method development and validation. The technician will also help maintain laboratory operations, ensure regulatory compliance, and support continuous improvement initiatives.
Key Responsibilities:
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Analytical Testing (HPLC & Wet Chemistry):
Perform precise qualitative and quantitative chemical analyses using HPLC and other advanced analytical instrumentation (e.g., UV-Vis, FTIR, GC, titration, pH meters). Prepare calibration curves, standards, and control samples. Interpret chromatograms, identify deviations, and ensure accurate documentation in compliance with cGMP/GLP standards.
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Method Development & Validation:
Participate in the development, optimization, and validation of HPLC and other analytical methods. Assist in writing and revising SOPs, test methods, and protocols. Conduct method robustness and Gage R&R studies to ensure reproducibility and accuracy.
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Root Cause & Deviation Analysis:
Investigate out-of-specification (OOS) or out-of-trend (OOT) results through root cause analysis. Work collaboratively with Quality Assurance and Production teams to resolve quality issues and implement corrective actions.
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Raw Material & In-Process Testing:
Test raw materials and in-process samples according to established specifications. Place non-conforming materials on hold and escalate findings as needed.
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Instrument Calibration & Maintenance:
Calibrate, maintain, and troubleshoot HPLC systems and other analytical equipment. Ensure all instruments are in proper working order and maintain calibration records per regulatory standards.
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Compliance & Documentation:
Maintain meticulous and timely records of all analyses, instrument logs, and quality reports in compliance with ISO, cGMP, and FDA guidelines. Support internal and external audits as required.
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Training & Mentorship:
Train junior technicians on HPLC and general laboratory practices. Contribute to the development and continuous improvement of QC training materials and programs.
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Inventory & Sample Management:
Maintain stock levels of HPLC columns, solvents, and reagents. Organize retain samples and ensure proper labeling, storage, and traceability.
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Lab Safety & Housekeeping:
Follow all safety protocols, maintain a clean and organized lab environment, and support initiatives to improve safety and efficiency.
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Flexibility & Team Support:
Willingness to support alternate shifts, cover absences, and contribute to cross-functional projects as required.
Qualifications:
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Education:
Bachelor’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific field.
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Experience:
At least 5 years of laboratory experience, with a strong focus on HPLC analysis in a quality control or pharmaceutical/chemical manufacturing environment.
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Technical Proficiency:
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Expert-level proficiency with HPLC operation, maintenance, and troubleshooting.
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Familiarity with chromatographic data systems (e.g., Empower, ChemStation, Chromeleon).
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Solid understanding of analytical chemistry principles, method validation, and instrument qualification.
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Working knowledge of cGMP, GLP, and ISO 9001/17025 requirements.
Soft Skills:
Strong attention to detail and problem-solving skills.
Excellent organizational and communication skills.
Ability to manage multiple priorities and work independently or as part of a team.
Comfortable using LIMS and other laboratory documentation systems.
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