QC Investigator Lead — Data Integrity & OOS/OOT

Piramal Pharma Limited; United States; 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, assess data integrity, and drive CAPA activities in a cGMP QC lab environment. The role requires strong knowledge of FDA/21 CFR 11, ALCOA+ and cross-functional collaboration for impactful decision-making.

The Senior QC Analyst will review analytical records, LIMS entries, and instrument outputs, ensuring accuracy, traceability, and regulatory compliance while mentoring junior staff and

Qualifications

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or related scientific discipline required.
• Minimum five (5) years of pharmaceutical QC laboratory experience in a GMP-regulated environment.
• Experience authoring or leading laboratory investigations, including OOS/OOT assessments and CAPA.
• Hands-on experience with HPLC and other analytical techniques (GC, UV-Vis, etc.).
• Strong data integrity, regulatory knowledge, and documentation practices.

Responsibilities

• Lead and complete laboratory investigations (OOS/OOT, atypical results, deviations).
• Perform and review laboratory assessments of method requirements, system suitability, and data integrity.
• Coordinate cross-functional collaboration to support investigations and product impact assessments.
• Maintain audit trails and ensure data traceability in records and reports.
• Develop CAPAs with owners, due dates, and measurable effectiveness checks.
• Provide training and mentoring on data integrity and investigation practices.

Skills

OOS/OOT investigations

CAPA development

Data integrity

Laboratory investigations

HPLC

Education

Bachelor’s degree in Chemistry

Advanced degree preferred

Tools

LIMS

SAP

Chromatography data systems

Job description

Piramal Pharma Solutions is seeking a Senior Quality Control Analyst to lead laboratory investigations, assess data integrity, and drive CAPA activities in a cGMP QC lab environment. The role requires strong knowledge of FDA/21 CFR 11, ALCOA+ and cross-functional collaboration for impactful decision-making.

The Senior QC Analyst will review analytical records, LIMS entries, and instrument outputs, ensuring accuracy, traceability, and regulatory compliance while mentoring junior staff and