Senior Quality Investigator: Lab Data & OOS/OOT

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Specialist for Laboratory Investigations & Data Integrity in Bucks County. You will lead investigations, assess root cause, and ensure data integrity across analytical records.

The role requires review of LIMS, chromatographic data, and regulatory compliance with FDA/ICH; collaboration with QA, Manufacturing, and Regulatory Affairs; drive CAPA effectiveness and closure.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, or related field.
• Minimum five years of QC laboratory experience in a GMP setting.
• Experience authoring or leading investigations (OOS/OOT) and CAPA.
• Knowledge of FDA 21 CFR Parts 210/211 and data integrity concepts.

Responsibilities

• Lead and coordinate laboratory investigations including OOS/OOT and deviations.
• Phase I laboratory assessments of method and instrument controls.
• Support full-scale investigations with cross-functional teams.
• Maintain oversight of OOS/OOT records through closure.
• Apply root-cause analysis to determine contributing and systemic factors.
• Develop CAPAs with owners, due dates, and effectiveness checks.
• Perform independent data review of raw data and reports.
• Ensure ALCOA+ data integrity and audit-trail compliance.

Skills

Laboratory investigations

OOS/OOT assessments

CAPA development

Data review

Analytical testing

HPLC

Education

Bachelor’s degree in Chemistry or related field

Advanced scientific degree preferred

Tools

LIMS

HPLC

Chromatography Data Systems

SAP

Job description

Piramal Pharma Solutions is seeking a Senior Quality Specialist for Laboratory Investigations & Data Integrity in Bucks County. You will lead investigations, assess root cause, and ensure data integrity across analytical records.

The role requires review of LIMS, chromatographic data, and regulatory compliance with FDA/ICH; collaboration with QA, Manufacturing, and Regulatory Affairs; drive CAPA effectiveness and closure.