Senior QC Analyst: Data Integrity & Audit Readiness

Piramal Critical Care, Inc.; Bethlehem (Northampton County); On-site; USD 70,000 - 95,000; Full time

Job summary

Piramal Critical Care, Inc. is seeking a Senior Quality Control Analyst to support testing of in-process material, bulk drug substance, finished drug product, and stability samples.

You will ensure data integrity, audit readiness, and compliant documentation across cGMP environments. The role involves instrument calibration, electronic systems oversight, and collaboration with internal and regulatory audits.

Qualifications

• Bachelor’s degree or Associate’s degree in science.
• 3+ years of experience in a QC lab environment.
• Knowledge of cGMP, quality and safety norms in a regulated industry.
• Experience with data integrity and electronic compliance is preferred.
• Experience supporting internal, customer or regulatory audits/inspections preferred.

Responsibilities

• Perform testing on in-process material, bulk drug substance, finished drug product, and stabilities.
• Maintain QC compliance with electronic systems and computerized laboratory applications.
• Assist in preparing responses to audit observations and information requests.
• Serve as a QC Data Integrity and Compliance (DICO) Champion.
• Perform calibration and troubleshooting on instruments (GC, HPLC, UV/Vis, IR, etc.).
• Prepare quality metrics for turnaround times and data trends.
• Oversee training of new hires and conduct peer data reviews.

Skills

Critical Thinking

Customer service

Data Integrity Champion

Analytical Data

Electronic Lab Systems

Audit Readiness

Communication skills

Confidentiality

Training skills

Education

Science degree

Tools

SAP

MS Office

Ensur

Openlab

LabX

TrackWise

CaliberLIMS

Job description

Piramal Critical Care, Inc. is seeking a Senior Quality Control Analyst to support testing of in-process material, bulk drug substance, finished drug product, and stability samples.

You will ensure data integrity, audit readiness, and compliant documentation across cGMP environments. The role involves instrument calibration, electronic systems oversight, and collaboration with internal and regulatory audits.