Quality Control Investigator: OOS/OOT & Data Integrity Lead

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 65,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions seeks a skilled Quality Control Analyst to lead laboratory investigations, review analytical data, and ensure data integrity in a cGMP QC lab. You will coordinate OOS/OOT investigations, develop CAPAs, and partner with QA and manufacturing to drive timely closure.

The role requires 5+ years in QC labs, strong HPLC skills, and expertise in ALCOA+ data handling, with a focus on compliant, accurate analytical review and problem solving.

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related field is required.
• Minimum five years of pharmaceutical QC laboratory experience in a GMP environment.
• Experience authoring or leading laboratory investigations (OOS/OOT) and CAPA development.
• Strong data integrity and regulatory knowledge (FDA 21 CFR 11, ALCOA+).
• Hands-on experience with HPLC and related instrumental techniques.

Responsibilities

• Lead, author, coordinate, and complete laboratory investigations (OOS, OOT, atypical results).
• Conduct prompt Phase I laboratory assessments of methods, reagents, instruments, and processing parameters.
• Support full-scale investigations with cross-functional teams to assess product impact.
• Maintain oversight of OOS/OOT records from initiation through closure.
• Apply root-cause analysis to determine assignable vs systemic causes and document hypotheses.
• Develop CAPAs with owners, due dates, and effectiveness checks.
• Review raw data, metadata, and audit trails to ensure data integrity and compliance.
• Ensure traceability and compliance of laboratory data in LIMS and reports.
• Prepare risk-based recommendations and communicate findings to QC leadership.
• Support inspection readiness and respond to customer/regulatory inquiries.

Skills

OOS/OOT investigations

Data integrity

Root-cause analysis

GxP quality control

Analytical data review

Education

Bachelor’s degree in Chemistry / Pharmaceutical Sciences

Advanced degree preferred

Tools

LIMS

HPLC

Chromatography data systems

SAP

Job description

Piramal Pharma Solutions seeks a skilled Quality Control Analyst to lead laboratory investigations, review analytical data, and ensure data integrity in a cGMP QC lab. You will coordinate OOS/OOT investigations, develop CAPAs, and partner with QA and manufacturing to drive timely closure.

The role requires 5+ years in QC labs, strong HPLC skills, and expertise in ALCOA+ data handling, with a focus on compliant, accurate analytical review and problem solving.