Quality Analyst

Piramal Pharma Solutions; Sellersville (Bucks County); On-site; USD 70,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Chemistry Analyst II to perform routine analytical testing using GC, HPLC and UPLC in support of product release, stability and studies. Candidates should be proficient in chromatographic analysis, sample prep, instrument operation and data processing within a GMP/GLP environment.

The role involves method transfers, investigations of atypical results, and collaboration with QA, Manufacturing and R&D to prioritize testing and ensure compliance and

Qualifications

• Requires strong technical competency in chromatographic analysis and sample preparation.
• Experience with data processing and troubleshooting in a GMP/GLP laboratory.

Responsibilities

• Perform qualitative and quantitative analysis using GC, HPLC, UPLC and related systems.
• Prepare samples, standards, diluents and mobile phases per SOPs.
• Execute instrument setup, calibration, system suitability checks and routine maintenance.
• Process and interpret chromatographic data using Empower or equivalent.
• Review chromatograms for peak integrity and system suitability criteria.
• Document analytical activities in notebooks, LIMS and controlled forms per GDP.

Skills

GC

HPLC

UPLC

Empower

GMP/GLP

LIMS

Tools

LIMS

Job description

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.

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.

Key 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 Empoweror 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.