Senior QC Analyst - Investigations & Data Integrity

piramalpharma; 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 and complete investigations, OOS/OOT assessments, CAPA development, and review analytical data in a cGMP lab. This role requires scientific judgment and timely action to closure.

You will review analytical testing of raw materials, finished products, stability samples, and special requests, ensuring data integrity, traceability, and regulatory compliance in a fast-paced

Qualifications

• Regulatory and corporate requirements: Adhere to FDA guidance and cGMP expectations.
• Values: integrity, scientific rigor, transparency, ownership, respectful challenge.

Responsibilities

• Laboratory Investigation Ownership: Lead and complete investigations (OOS/OOT) and CAPA development.
• Review of analytical data: Independent review of raw data, chromatograms, and narratives for traceability and compliance.
• OOS/OOT governance: Maintain oversight of records from initiation to closure and ensure proper documentation.

Job description

Piramal Pharma Solutions is seeking a Senior Quality Specialist, Laboratory Investigations & Data Integrity, to lead and complete investigations, OOS/OOT assessments, CAPA development, and review analytical data in a cGMP lab. This role requires scientific judgment and timely action to closure.

You will review analytical testing of raw materials, finished products, stability samples, and special requests, ensuring data integrity, traceability, and regulatory compliance in a fast-paced