QC Analyst II

piramalpharma; Sellersville (Bucks County); On-site; USD 60,000 - 80,000; Full time

Job summary

Piramal Pharma Solutions is seeking a QC Analyst II to join our GMP-compliant laboratory in the United States. The role focuses on routine analytical testing (GC, HPLC, UPLC) to support product release, stability studies, and method development with strong emphasis on data integrity and regulatory compliance.

You will prepare samples, operate instruments, process data, and collaborate with QA, Manufacturing, and R&D to ensure robust testing under GDP guidelines.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology or related field with laboratory coursework.
• Minimum 2 years of laboratory experience, preferably GMP-regulated.
• Hands-on experience with wet chemistry, dissolution, FTIR, KF moisture, UV/Vis, titrations, pH, and related QC tests.

Responsibilities

• Perform qualitative and quantitative analysis using GC, HPLC, UPLC and related systems.
• Prepare samples, standards, diluents, and mobile phases per SOPs.
• Set up instruments, calibrate, and perform system suitability checks.
• Process and interpret chromatographic data using software (e.g., Empower).
• Review chromatograms for peak integrity and compliance with SOPs.
• Document all analytical activities in notebooks, LIMS, and forms per GDP/regulatory standards.
• Investigate atypical results and root-cause analysis.
• Support method transfers, verifications, and validations.
• Maintain laboratory readiness and proper labeling of reagents.

Skills

GC/HPLC/UPLC

Chromatography

Data processing

Instrument maintenance

Education

Bachelor’s degree in Chemistry/Biology/Microbiology

Tools

Empower software

Job description

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

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.

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.

EDUCATION/EXPERIENCE

• 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.

job competencies

• 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.

job conditions

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department.

Physical Demands : Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected. Long periods of standing and walking can be expected in this position. This position may require long periods of sitting, typing, computer entry or looking at a computer.

Work Environment : Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all PPS staff work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical manufacturing equipment and processes. Potential limited exposure to hazardous chemicals. Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.

equal employment opportunity.

Piramal Pharma Solutions is proud to be an Equal Employment Oppo