Quality Control Investigator: Data Integrity Lead

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 65,000 - 105,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Quality Control Analyst to lead investigations, review analytical data, and ensure data integrity in a cGMP setting. The role emphasizes OOS/OOT handling, regulatory compliance, and CAPA development across raw materials and finished products.

The analyst will work under QA oversight to ensure timely root-cause analysis, robust documentation, and cross-functional collaboration with Manufacturing and Regulatory Affairs. A solid QC background is required.

Qualifications

• Bachelor’s degree in Chemistry or related field is required.
• Minimum five (5) years of pharmaceutical QC laboratory experience.
• Experience with OOS/OOT investigations, CAPA development, and data review.
• Strong knowledge of data integrity, GLP/GMP regulations, and ALCOA+.

Responsibilities

• Lead and document laboratory investigations including OOS/OOT events.
• Review chromatographic data, calculations, and instrument outputs for accuracy.
• Coordinate CAPAs and ensure timely closure with QMS alignment.
• Assess data integrity and trail for compliance during investigations.
• Support audits and ensure documentation readiness for regulatory review.

Skills

Laboratory investigations

OOS/OOT assessments

CAPA development

Data integrity

HPLC knowledge

Analytical data review

Regulatory knowledge

ALCOA+ principles

Education

Bachelor's degree in Chemistry

Tools

LIMS

Job description

Piramal Pharma Solutions is seeking a Quality Control Analyst to lead investigations, review analytical data, and ensure data integrity in a cGMP setting. The role emphasizes OOS/OOT handling, regulatory compliance, and CAPA development across raw materials and finished products.

The analyst will work under QA oversight to ensure timely root-cause analysis, robust documentation, and cross-functional collaboration with Manufacturing and Regulatory Affairs. A solid QC background is required.