QC Stability Analyst II: Stability Testing & Compliance

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions in the United States seeks a QC Analyst II - Stability to perform analytical testing of stability samples using HPLC, UPLC, GC and other methods, ensuring compliance with cGMP. You will execute stability studies, review data, and support investigations while collaborating with QA, Regulatory Affairs, and Manufacturing to maintain a robust stability program.

Bachelor's degree in a chemical science and 2–4 years in GMP QC preferred; strong documentation and data integrity

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Microbiology, or related scientific discipline.
• Minimum 2-4 years of pharmaceutical Quality Control laboratory experience in a cGMP-regulated environment.
• Experience performing analytical testing using HPLC, UPLC, and/or GC instrumentation.
• Experience supporting stability studies and stability testing preferred.
• Experience with dissolution, FTIR, Karl Fischer Moisture, UV-Vis, pH, conductivity, and wet chemistry testing preferred.
• Experience using laboratory systems such as Empower, LIMS, or equivalent data management systems preferred.

Responsibilities

• Perform analytical testing of stability samples using HPLC, UPLC, GC, dissolution, UV-Vis, FTIR, and other compendial methods.
• Execute stability studies in accordance with approved protocols, product commitments, and internal procedures.
• Prepare samples, standards, diluents, mobile phases, and reagents required for stability testing.
• Operate, calibrate, troubleshoot, and perform routine maintenance on analytical instrumentation.
• Process, integrate, review, and interpret analytical data using Empower or equivalent software.
• Review chromatograms for peak integrity, retention time consistency, system suitability, and compliance with specifications.
• Support stability sample inventory management, pull schedules, storage conditions, and testing timelines.
• Trend and evaluate stability data to identify potential quality concerns, OOT results, and product performance trends.
• Document all analytical activities in laboratory notebooks, LIMS, and controlled records in accordance with GDP requirements.
• Participate in laboratory investigations related to OOS, OOT, atypical results, and stability-related deviations.
• Support method transfers, method verifications, and method validation activities as required.
• Assist with preparation and review of stability protocols, reports, and supporting documentation.
• Support regulatory inspections, customer audits, and internal audits related to stability activities.
• Maintain laboratory readiness through proper documentation, instrument logbooks, reagent control, and compliance with safety requirements.
• Collaborate with QA, Manufacturing, Regulatory Affairs, Stability Program Management, and other departments to support business priorities.

Skills

Analytical testing

Chromatographic techniques

Data interpretation

Quality control

Education

Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

Dissolution

FTIR

Karl Fischer

Job description

Piramal Pharma Solutions in the United States seeks a QC Analyst II - Stability to perform analytical testing of stability samples using HPLC, UPLC, GC and other methods, ensuring compliance with cGMP. You will execute stability studies, review data, and support investigations while collaborating with QA, Regulatory Affairs, and Manufacturing to maintain a robust stability program.

Bachelor's degree in a chemical science and 2–4 years in GMP QC preferred; strong documentation and data integrity