Senior Quality Control Analyst — Data Integrity Champion

Piramal Pharma Ltd; Bethlehem (Northampton County); On-site; USD 80,000 - 110,000; Full time

Job summary

Piramal Critical Care is seeking a Senior Quality Control Analyst to join our QC lab in the United States. The role involves analytical testing of in-process material, bulk drug substance, finished product and stability samples, with emphasis on data integrity and regulatory readiness.

You will support audits, maintain instrument calibration, and contribute to CAPA and deviation investigations while ensuring cGMP compliance and accurate documentation across electronic systems.

Qualifications

• Bachelor’s or Associate’s degree in science with 3+ years in a QC lab.
• Experience with data integrity, electronic compliance, and regulatory audits is preferred.
• Familiarity with cGMP, quality norms and required lab documentation.

Responsibilities

• Perform analytical testing of in-process material, bulk API, finished drug product, and stability samples.
• Support audits and inspections, and investigate deviations.
• Maintain calibration and minor troubleshooting on lab instruments (GC, HPLC, UV/Vis, IR, etc).
• Prepare quality metrics for in-process, API, and FG turnaround times.
• Ensure data integrity and compliance across electronic systems.

Skills

Critical Thinking

Customer service

DICO Champion

Data analysis

Electronic lab systems

Audit readiness

Communication

Problem solving

Confidentiality

Coaching

Education

Science degree (BSc/AS)

Tools

SAP

MS Office

Ensur

Openlab

LabX

TrackWise

CaliberLIMS

Job description

Piramal Critical Care is seeking a Senior Quality Control Analyst to join our QC lab in the United States. The role involves analytical testing of in-process material, bulk drug substance, finished product and stability samples, with emphasis on data integrity and regulatory readiness.

You will support audits, maintain instrument calibration, and contribute to CAPA and deviation investigations while ensuring cGMP compliance and accurate documentation across electronic systems.