Senior Stability QC Analyst | Drive Quality Impact

PPL Healthcare LLC; Sellersville (Bucks County); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Stability programs

ICH guidelines

Analytical testing

Data analysis

Technical writing

Quality control

Cross-functional collaboration

Educación

Bachelor's in Chemistry

Herramientas

HPLC

UPLC

GC

Dissolution

Empower

LIMS

TrackWise

Descripción del empleo

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.