Senior QC Investigator - Data Integrity & OOS/OOT Lead

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Specialist, Laboratory Investigations & Data Integrity, to lead OOS/OOT investigations and data-review activities in a cGMP lab. The role emphasizes root-cause analysis, regulatory compliance, and timely CAPA development.

The Senior QC Analyst will review analytical data, ensure ALCOA+ data integrity, and coordinate with QA, Manufacturing, and Regulatory teams to drive closures and maintain inspection readiness.

Qualifications

• Education: Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline; advanced degree preferred.
• Experience: Minimum five (5) years of pharmaceutical QC laboratory experience in a GMP environment.
• Investigation experience: authoring or leading laboratory investigations including OOS/OOT.
• Analytical expertise: hands-on experience with HPLC and other techniques.
• Regulatory knowledge: FDA OOS/data-integrity guidance, 21 CFR Parts 210/211/11; USP/EP knowledge.

Responsibilities

• Lead, author, coordinate, and complete laboratory investigations involving OOS, OOT, deviations and data integrity activities.
• Perform independent review of raw data, chromatographic processing, audit trails, and LIMS entries for accuracy and traceability.
• Coordinate cross-functional investigations with QA, Manufacturing, Regulatory Affairs.
• Develop CAPAs, track effectiveness, and ensure timely closure.
• Ensure data integrity and ALCOA+ principles are followed in all records.

Skills

Laboratory investigations

Data integrity

FDA/21 CFR knowledge

OOS/OOT assessment

Education

Bachelor’s degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences

Tools

Job description

Piramal Pharma Solutions is seeking a Senior Quality Specialist, Laboratory Investigations & Data Integrity, to lead OOS/OOT investigations and data-review activities in a cGMP lab. The role emphasizes root-cause analysis, regulatory compliance, and timely CAPA development.

The Senior QC Analyst will review analytical data, ensure ALCOA+ data integrity, and coordinate with QA, Manufacturing, and Regulatory teams to drive closures and maintain inspection readiness.