QC Analyst II

Piramal Enterprises Ltd

Sellersville, PA

JOB DETAILS
SKILLS
Analysis Skills, Antibodies, Application Programming Interface (API), Biotech and Pharmaceutical, Calibration, Chemistry, Chromatographic Assay, Chromatographic Systems, Chromatography, Clinical Trial, Contract Manufacturing, Corrective Action, Data Processing, Documentation, Dosage Forms, Drug Development, Drug Discovery, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Gas Chromatography, High Performance Liquid Chromatography (HPLC), Identify Issues, Laboratory Analysis, Laboratory Information Management System (LIMS), Laboratory Notebook, Laboratory Techniques, Liquid Chromatography, Manufacturing, Medical Products, Network Integration, Problem Solving Skills, Procedure Development, Product Support, Qualitative Analysis, Quality Assurance, Quality Assurance Methodology, Quality Control, Quantitative Analysis, Regulations, Regulatory Compliance, Research & Development (R&D), Root Cause Analysis, Safety Compliance, Safety Training, Sample/Specimen Processing, Standard Operating Procedures (SOP), Testing
LOCATION
Sellersville, PA
POSTED
14 days ago

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

QC Analyst II

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 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.

About the Company

P

Piramal Enterprises Ltd