Senior Stability QC Analyst: Drive Compliance and Trends

Piramal Pharma Limited; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior QC Analyst - Stability to support the site stability program and ensure on-time completion of testing per cGMP and ICH guidelines. The role involves analytical testing, data review, investigations and cross-functional collaboration with QA, Regulatory Affairs and Operations.

The candidate will manage stability studies, maintain documentation, and participate in audits and continuous improvement initiatives while mentoring junior staff.

Qualifications

• Minimum 7 years of QC laboratory experience in pharma/biotech.
• 3+ years directly supporting stability programs.
• Experience with stability data review and investigations.
• Experience with HPLC/UPLC/GC and dissolution systems.
• Ability to author/review stability protocols and reports.

Responsibilities

• Coordinate and execute stability studies per approved protocols and ICH guidelines.
• Perform analytical testing using HPLC, UPLC, GC and dissolution systems.
• Monitor inventories, pull schedules, storage conditions and testing timelines.
• Review, trend and evaluate stability data for OOT and other quality concerns.
• Generate and maintain stability documentation, sample inventories and reports.
• Lead investigations including OOS/OOT and stability-related deviations.
• Support audits and inspections; ensure cGMP and data integrity.
• Train and mentor QC analysts on stability procedures and regulatory requirements.

Skills

Stability testing

Data analysis

Technical writing

Collaboration

Problem solving

Education

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

Dissolution

Empower

LIMS

TrackWise

Job description

Piramal Pharma Solutions is seeking a Senior QC Analyst - Stability to support the site stability program and ensure on-time completion of testing per cGMP and ICH guidelines. The role involves analytical testing, data review, investigations and cross-functional collaboration with QA, Regulatory Affairs and Operations.

The candidate will manage stability studies, maintain documentation, and participate in audits and continuous improvement initiatives while mentoring junior staff.