Stability QC Analyst II: Precision Testing & Compliance

PPL Healthcare LLC; Sellersville (Bucks County); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions is seeking a QC Analyst II - Stability to perform analytical testing of stability samples and support the Stability Program. You will execute studies, review data, and ensure compliance with cGMP and ICH guidelines while collaborating with QA, Regulatory Affairs, and Manufacturing.

The role requires a Bachelor’s degree in a related science and 2–4 years of QC laboratory experience, with hands-on use of HPLC/UPLC/GC and Empower or LIMS systems in a regulated environment.

Formación

• Bachelor's degree in a scientific discipline.
• 2-4 years of pharmaceutical QC lab experience in a cGMP environment.
• Experience with analytical testing using HPLC/UPLC/GC.
• Experience supporting stability studies and related testing.

Responsabilidades

• Perform analytical testing of stability samples using HPLC, UPLC, GC, dissolution, UV-Vis and other compendial methods.
• Execute stability studies per approved protocols and internal procedures.
• Prepare samples, reagents, mobile phases and standards for stability testing.
• Operate, calibrate and maintain analytical instrumentation; troubleshoot as needed.
• Review data and interpret chromatograms for quality and regulatory compliance.
• Document all activities in LIMS and notebooks following GDP and cGMP.

Conocimientos

HPLC/UPLC/GC

Dissolution

FTIR

Karl Fischer

Data Integrity

GDP

cGMP

Educación

Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences/Microbiology

Herramientas

Empower

LIMS

Descripción del empleo

Piramal Pharma Solutions is seeking a QC Analyst II - Stability to perform analytical testing of stability samples and support the Stability Program. You will execute studies, review data, and ensure compliance with cGMP and ICH guidelines while collaborating with QA, Regulatory Affairs, and Manufacturing.

The role requires a Bachelor’s degree in a related science and 2–4 years of QC laboratory experience, with hands-on use of HPLC/UPLC/GC and Empower or LIMS systems in a regulated environment.