Job Description
Job Summary
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The QC Associate performs analytical testing and supports quality control activities within a cGMP-regulated pharmaceutical manufacturing environment, ensuring raw materials, in-process samples, and finished products meet established quality standards.
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Responsibilities
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- Perform routine analytical testing using laboratory techniques such as HPLC, GC, FTIR, and moisture analysis.
- Prepare samples, reagents, and standards for testing.
- Review and document laboratory results in compliance with cGMP requirements and SOPs.
- Maintain accurate laboratory records and ensure data integrity.
- Support analytical method development, validation, and troubleshooting as needed.
- Investigate out-of-specification (OOS) results and laboratory deviations.
- Maintain laboratory equipment, supplies, and a clean, compliant work environment.
- Support product release testing, audits, and regulatory inspections.
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Qualifications
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- Associate’s or Bachelor’s degree in Chemistry, Biology, or a related scientific field.
- Experience in a QC laboratory within pharmaceutical manufacturing or another GMP-regulated environment preferred.
- Familiarity with analytical instrumentation, including HPLC, GC, and FTIR, is an advantage.
- Knowledge of cGMP regulations, SOPs, laboratory documentation, and data integrity.
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