Senior QC Investigator - Lab Data Integrity

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 95,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions in the United States is seeking a Senior Quality Control Analyst to lead investigations, OOS/OOT assessments, CAPA development, and comprehensive data integrity reviews in a cGMP laboratory.

The role requires applying regulatory judgment, reviewing analytical data, and collaborating across QA, Regulatory Affairs, and Manufacturing to drive timely closure of investigations and ensure data traceability.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology or related field is required.
• Advanced scientific degree is preferred.
• Minimum five (5) years of pharmaceutical Quality Control laboratory experience in a GMP environment.
• Experience authoring or leading laboratory investigations (OOS/OOT) and CAPA development.
• Strong working knowledge of FDA OOS and data-integrity guidance; use of ALCOA+ principles.

Responsibilities

• Lead and complete laboratory investigations, including OOS/OOT assessments and CAPA development.
• Review raw data, chromatograms, and LIMS records for accuracy and traceability.
• Collaborate across QA, Regulatory Affairs, Manufacturing to resolve investigations.
• Maintain oversight of investigation records and ensure timely closure.
• Support inspection readiness and regulatory audits.

Education

Bachelor's degree in Chemistry or related field

Advanced degree preferred

Tools

LIMS

Chromatography Data Systems

SAP

Job description

Piramal Pharma Solutions in the United States is seeking a Senior Quality Control Analyst to lead investigations, OOS/OOT assessments, CAPA development, and comprehensive data integrity reviews in a cGMP laboratory.

The role requires applying regulatory judgment, reviewing analytical data, and collaborating across QA, Regulatory Affairs, and Manufacturing to drive timely closure of investigations and ensure data traceability.