QC Analyst II

Piramal Pharma•Sellersville, PA

5d•Onsite

About The Position

The Chemistry Analyst II performs routine analytical testing using Liquid Chromatography (LC) and Gas Chromatography (GC) techniques in support of product release, stability and studies. This role requires strong technical competency in chromatographic analysis, sample preparation, instrument operation, data processing, and troubleshooting within a GMP/GLP laboratory environment.

Requirements

Bachelor's degree in Chemistry, Biology, Microbiology, or another related scientific discipline with relevant laboratory coursework.
Minimum 2 years of laboratory experience, preferably in a GMP-regulated environment.
Hands-on experience with wet chemistry, balances, dissolution, FTIR, Karl Fischer Moisture (KFM), UV/Vis, titrations, viscosity, particle size distribution (PSD), pH, and conductivity testing.
Strong understanding of laboratory safety practices and proper PPE usage.
Working knowledge of cGMP requirements and Good Documentation Practices (GDP).
Knowledge of USP and EP compendial testing requirements.
Ability to work independently with minimal supervision and minimal laboratory errors.
Proficiency with analytical techniques including HPLC, FTIR, UV-Vis, Karl Fischer, dissolution, wet chemistry, pH testing, reagent preparation, and volumetric solutions.

Responsibilities

Perform qualitative and quantitative analysis using GC, HPLC, UPLC , and related chromatographic systems in accordance with approved test methods and SOPs.
Prepare samples, standards, diluents, and mobile phases following established laboratory procedures and good documentation practices.
Execute instrument setup, calibration, system suitability checks, and routine maintenance to ensure reliable performance.
Process, integrate, and interpret chromatographic data using software such as Empower or equivalent.
Review chromatograms for peak integrity, retention time consistency, baseline quality, and compliance with system suitability criteria.
Document all analytical activities in laboratory notebooks, LIMS, and controlled forms in accordance with GDP and regulatory expectations.
Conduct investigations into atypical results, instrument issues, or method deviations, including root‑cause analysis and corrective actions.
Support method transfers, verifications, and validations by executing protocols and generating high‑quality analytical data.
Maintain laboratory readiness by ensuring proper reagent labeling, instrument logbook completion, and adherence to safety and compliance requirements.
Collaborate with cross‑functional teams (QA, Manufacturing, R&D) to support testing priorities and resolve technical issues.