Senior Stability QC Analyst - Data-Driven Quality

Piramal Pharma Limited; Sellersville (Bucks County); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Piramal Pharma Solutions is seeking a Senior QC Analyst - Stability to lead and execute the site's stability program, including testing, data review, and documentation in compliance with cGMP and ICH guidelines. You will collaborate with Quality Control, QA, Regulatory Affairs, and Operations to ensure timely product lifecycle support.

The role requires strong analytical chemistry skills, experience with stability data interpretation, and ability to manage multiple studies in a fast-paced

Competenze

• 7+ years of Quality Control laboratory experience in pharma/biotech.
• 3+ years direct experience supporting stability programs in a cGMP environment.
• Experience performing stability testing and managing stability studies.
• Experience with HPLC, UPLC, GC, and dissolution systems.
• Experience drafting/studying stability protocols and reports preferred.
• Experience supporting regulatory inspections and customer audits preferred.

Mansioni

• Coordinate and execute stability studies per approved protocols and ICH guidelines.
• Perform analytical testing of stability samples using HPLC/UPLC/GC/dissolution.
• Monitor inventories, pull schedules, storage conditions, and timelines.
• Review, trend, and evaluate stability data; identify OOT results and quality concerns.
• Generate and maintain stability study docs, inventories, protocols, and reports.
• Lead investigations including OOS, OOT, deviations; support CAPAs.
• Support stability program inspections and audits; assist customers as needed.
• Maintain stability chambers; assist with temperature mapping and alarms.
• Assist method validation, verification, and transfers; support continuous improvement.
• Train QC Analysts on stability procedures and regulations.

Conoscenze

Stability program management

Analytical testing

Data analysis

Technical writing

Cross-functional collaboration

Regulatory inspections support

Strumenti

Empower

LIMS

TrackWise

Electronic QA systems

Descrizione del lavoro

Piramal Pharma Solutions is seeking a Senior QC Analyst - Stability to lead and execute the site's stability program, including testing, data review, and documentation in compliance with cGMP and ICH guidelines. You will collaborate with Quality Control, QA, Regulatory Affairs, and Operations to ensure timely product lifecycle support.

The role requires strong analytical chemistry skills, experience with stability data interpretation, and ability to manage multiple studies in a fast-paced