Chemist

Job Title: Quality Control Associate II, Analytical (full benefits)

Location: Bristol, Pennsylvania 19007

Job Summary

The Quality Control (QC) Associate II is responsible for routine and non-routine testing of raw materials, in-process samples, final product, and stability samples in support of GMP manufacturing . This role focuses on executing analytical method qualification/validation protocols, performing analytical testing, reviewing data, and ensuring compliance with applicable regulatory guidelines

Key Responsibilities

• Perform routine testing on raw materials, in-process samples , bulk drug substances, and final products using techniques such as HPLC, Empower
• Must have a solid understanding of compendial standards (USP, Ph. EUR, JP), wet chemistry techniques, and instrumental analyses (e.g., U/HPLC, GC, FTIR, KF).
• Conduct and support testing activities with external contract labs, including compendial methods.
• Execute analytical method qualification and validation protocols and prepare comprehensive reports. Perform stability studies as per protocol and generate clear, scientifically sound reports and trending analyses.
• Participate in method and equipment qualifications/validations within the QC lab.
• Review and verify QC data and associated documentation to ensure accuracy and compliance. Perform routine instrument calibrations and minor maintenance.
• Support and participate in laboratory investigations (OOS, OOT, atypical, invalid results), including root cause analysis and CAPA.

Qualifications & Requirements

• Bachelor’s degree in scientific discipline (Chemistry, Biology etc.)
• 2 years of QC testing experience in a GMP manufacturing environment