Senior QC Investigator: Data Integrity & OOS/OOT

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Control Analyst to lead laboratory investigations, review analytical data, and drive CAPA effectiveness in a cGMP environment. The role emphasizes data integrity, regulatory compliance, and cross-functional collaboration within QA/QC teams.

The incumbent will oversee OOS/OOT cases, audit trails, and instrument performance, ensuring timely and compliant closure of investigations, while maintaining exceptional data quality and product safety.

Qualifications

• Bachelor’s degree in Chemistry or related field is required.
• Minimum five years of GMP QC laboratory experience with analytical testing and data review.
• Experience authoring or leading investigations (OOS/OOT, root-cause analysis) and CAPA.
• Strong knowledge of FDA OOS guidance, 21 CFR Parts 210/211/11, USP/EP.
• Experience with LIMS and chromatographic data systems.

Responsibilities

• Lead and coordinate laboratory investigations (OOS/OOT, atypical results) with evidence and timelines.
• Review chromatograms, calculations, metadata and audit trails for data integrity.
• Develop and track risk-based CAPA and ensure effectiveness.
• Ensure data traceability and compliance of laboratory systems and methods.
• Support audit readiness and cross-functional investigation activities.

Skills

Laboratory investigations

OOS/OOT assessments

Data integrity

HPLC

Education

Bachelor’s degree in Chemistry

Tools

LIMS

Job description

Piramal Pharma Solutions is seeking a Senior Quality Control Analyst to lead laboratory investigations, review analytical data, and drive CAPA effectiveness in a cGMP environment. The role emphasizes data integrity, regulatory compliance, and cross-functional collaboration within QA/QC teams.

The incumbent will oversee OOS/OOT cases, audit trails, and instrument performance, ensuring timely and compliant closure of investigations, while maintaining exceptional data quality and product safety.