Job Summary:
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.
Responsibilities:
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.
Qualifications:
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.
