Senior QC Investigator - OOS/OOT & Data Integrity Lead

Piramal Pharma Ltd; Sellersville (Bucks County); In loco; USD 95.000 - 135.000; Tempo pieno

Descrizione del lavoro

Piramal Pharma Solutions is seeking a Senior Quality Specialist, Laboratory Investigations & Data Integrity. The role leads laboratory investigations, OOS/OOT assessments, CAPA development, and comprehensive review of analytical data in a cGMP lab, reporting to the Associate Director QC.

The position requires strong scientific judgment to determine root cause, assess data impact, document conclusions, and drive timely closure while upholding ALCOA+ data integrity and regulatory compliance.

Competenze

• Bachelor’s degree in Chemistry or related scientific discipline is required; advanced degree preferred.
• Minimum five (5) years of pharmaceutical QC laboratory experience in a GMP environment with independent testing and data review.
• Experience authoring or leading laboratory investigations including OOS/OOT and CAPA development.
• Strong knowledge of chromatography, data integrity, and regulatory expectations (FDA 21 CFR Parts 210/211/11; USP/EP).

Mansioni

• Lead and coordinate laboratory investigations (OOS/OOT, atypical, deviations).
• Assess analyst execution, calculations, and instrument data during investigations.
• Coordinate cross-functional support for complex investigations and product-impact decisions.
• Review electronic records, audit trails, and data integrity controls.
• Perform or supervise independent data review of QC testing and reports.

Conoscenze

Attention to detail

Data review

Root-cause analysis

Written communication

Formazione

Bachelor’s degree in Chemistry or related

Strumenti

LIMS

HPLC

Descrizione del lavoro

Piramal Pharma Solutions is seeking a Senior Quality Specialist, Laboratory Investigations & Data Integrity. The role leads laboratory investigations, OOS/OOT assessments, CAPA development, and comprehensive review of analytical data in a cGMP lab, reporting to the Associate Director QC.

The position requires strong scientific judgment to determine root cause, assess data impact, document conclusions, and drive timely closure while upholding ALCOA+ data integrity and regulatory compliance.