Sr. QC Analyst -Stability

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Sr. QC Analyst - Stability to support and execute the site's Stability Program in a fast-paced pharmaceutical setting.

You will perform analytical testing, trend data, and lead investigations to ensure on-time product quality and regulatory compliance. The ideal candidate has 7+ years in QA/QC labs within pharma, with hands-on stability experience and strong skills in HPLC, UPLC, GC, and dissolution methodologies.

Qualifications

• Minimum 7 years of QA/QC lab experience in pharma.
• 3+ years supporting stability programs in a cGMP environment.
• Experience with HPLC, UPLC, GC, and dissolution systems.

Responsibilities

• Coordinate stability studies per protocols and ICH guidelines.
• Perform analytical testing of stability samples using HPLC/UPLC/GC.
• Monitor inventories, schedules, storage conditions, and timelines.
• Review and trend stability data for OOT and deviations.
• Generate stability documentation, reports, and records.
• Lead investigations including OOS/OOT and quality issues.

Skills

Stability programs

ICH guidelines

Analytical testing

Data analysis

Technical writing

Quality control

Cross-functional collaboration

Education

Bachelor's in Chemistry

Tools

HPLC

UPLC

GC

Dissolution

Empower

LIMS

TrackWise

Job description

About the Company

Be the First to Apply 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

Sr. QC Analyst -Stability

Job Description

The Senior QC Analyst - Stability is responsible for supporting and executing the site's Stability Program through the testing, monitoring, tracking, and documentation of stability samples in accordance with cGMP requirements, approved protocols, ICH guidelines, and regulatory commitments. This role performs analytical testing of stability samples, evaluates stability data and trends, coordinates stability studies, supports laboratory investigations, and ensures on-time execution of the site's stability program. The Senior QC Analyst serves as a subject matter expert for stability activities and partners with Quality Control, Quality Assurance, Regulatory Affairs, and Operations to maintain compliance and support product lifecycle management.

Essential Responsibilities

• Coordinate and execute stability studies in accordance with approved protocols, regulatory commitments, and ICH guidelines.
• Perform analytical testing of stability samples utilizing HPLC, UPLC, GC, dissolution, and other laboratory instrumentation.
• Monitor stability sample inventories, pull schedules, storage conditions, and testing timelines to ensure on-time completion.
• Review, trend, and evaluate stability data to identify Out-of-Trend (OOT) results and emerging quality concerns.
• Generate and maintain stability study documentation, sample inventories, protocols, summary reports, and supporting records.
• Perform data review and verification activities to support product release and annual product quality reviews.
• Lead and support laboratory investigations, including OOS, OOT, atypical, and stability-related deviations.
• Support stability program inspections, regulatory audits, and customer audits.
• Maintain stability chambers and support temperature mapping, qualification, monitoring, and alarm management activities.
• Support method validation, verification, method transfers, and continuous improvement initiatives.
• Train and mentor QC Analysts on stability-related procedures, testing techniques, and regulatory requirements.
• Ensure compliance with cGMP, GDP, data integrity requirements, and site procedures.

Experience

• Minimum 7 years of Quality Control laboratory experience within the pharmaceutical, biotechnology, or related regulated industry.
• Minimum 3 years of direct experience supporting pharmaceutical stability programs.
• Demonstrated experience performing stability testing and managing stability studies in a cGMP environment.
• Experience reviewing and trending stability data and supporting stability-related investigations.
• Experience with analytical instrumentation including HPLC, UPLC, GC, and dissolution systems.
• Experience authoring or reviewing stability protocols and stability reports preferred.
• Experience supporting regulatory inspections and customer audits preferred.

Knowledge, Skills & Abilities

• Strong understanding of pharmaceutical stability programs and ICH stability guidelines (Q1A through Q1E).
• Strong analytical chemistry and laboratory investigation skills.
• Expertise with HPLC, UPLC, GC, dissolution, and associated analytical methodologies.
• Experience interpreting long-term, accelerated, and ongoing stability data.
• Knowledge of OOS, OOT, deviations, CAPAs, and change control processes.
• Proficiency with Empower, LIMS, TrackWise, and electronic quality systems.
• Strong data analysis, trend evaluation, and technical writing skills.
• Ability to manage multiple stability studies and competing priorities in a fast-paced environment.
• Strong communication and collaboration skills across Quality, Regulatory Affairs, Manufacturing, and Technical Services.

Company Overview

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.

Equal Employment Opportunity

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.