Job Summary:
The Quality Control Analyst is responsible for ensuring that products meet established quality standards and regulatory requirements. This role involves performing routine and non-routine testing of raw materials, in-process samples, and finished products, as well as documenting and reporting results. The analyst plays a key role in identifying deviations, supporting investigations, and contributing to continuous improvement initiatives.
Key Responsibilities:
· Perform analytical testing using techniques such as HPLC, KF, GC, UV-Vis, FTIR, and wet chemistry.
· Conduct inspections and sampling of raw materials, intermediates, and finished goods.
· Maintain accurate and complete documentation in accordance with GMP and company SOPs.
· Review and interpret test results, identify deviations, and assist in root cause analysis.
· Support method development and validation activities.
· Ensure laboratory equipment is calibrated and maintained.
· Participate in internal audits and support external regulatory inspections.
· Collaborate with cross-functional teams including Manufacturing, QA, and R&D.
· Assist in the preparation of Certificates of Analysis and other quality documentation.
Qualifications:
· Bachelor’s degree in Chemistry, Biology, or a related scientific discipline.
· 2+ years of experience in a pharmaceutical, biotech, or manufacturing QC environment.
· Strong understanding of GMP, GLP, and regulatory guidelines (FDA, EMA, etc.).
· Proficiency in analytical instrumentation and software.
· Excellent attention to detail and organizational skills.
· Strong communication and problem-solving abilities.
Preferred Skills:
· Experience with LIMS or other laboratory data management systems.
· Knowledge of statistical analysis and quality control tools.
· Familiarity with ISO standards and ICH guidelines.
· Experience with enzyme assays
