QC Analyst II

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 52,000 - 76,000; Full time

Job summary

Piramal Pharma Solutions is seeking a QC Analyst II to support product release, stability and studies in a GMP/GLP laboratory. The role requires chromatographic proficiency, sample prep, instrument operation, data processing, and problem solving to ensure data quality.

The successful candidate will perform GC/HPLC/UPLC analyses, maintain instrument readiness, document results, and collaborate with QA, Manufacturing, and R&D to meet testing priorities.

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, or related discipline with relevant lab coursework.
• Minimum 2 years laboratory experience, preferably GMP-regulated.
• Hands-on wet chemistry experience and instrumental analysis (pH, dissolution, FTIR, Karl Fischer, UV-Vis).

Responsibilities

• Perform qualitative and quantitative analysis using GC, HPLC/UPLC, and related systems following approved test methods.
• Prepare samples, standards, diluents, and mobile phases per SOPs.
• Set up instruments, calibrate, perform system suitability checks and routine maintenance.
• Process and interpret chromatographic data using Empower or equivalent.
• Review chromatograms for peak integrity and compliance with criteria.
• Document all analytical activities in notebooks, LIMS, and forms per GDP.

Skills

HPLC/UPLC

GC

Sample prep

Data interpretation

Education

Bachelor's in Chemistry/Biology/Microbiology

Tools

Empower

LIMS

Job description

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, 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.

• 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

The successful candidate must meet one of the following education/experience combinations: 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 Opportunity and Affiduative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the‑counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.