Senior QC Analyst — Data Integrity & Audit Readiness

piramalpharma; Town of Bethlehem (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

Piramal Critical Care (PCC) is seeking a Senior Quality Control Analyst to perform testing on in-process materials, bulk drug substances, and finished drug products, while ensuring CGMP/GDP compliance. The role supports electronic systems, audit trails, and inspection readiness across QA functions.

The ideal candidate has 3+ years of QC experience in pharma, strong data integrity skills, and familiarity with regulatory expectations, contributing to timely audit responses and continuous

Qualifications

• Bachelor's or Associate degree in science required.
• 3+ years of QC experience in pharma or related field.
• Strong attention to data integrity and regulatory compliance.

Responsibilities

• Perform testing on in-process material, bulk drug substance, finished drug product, and stabilities.
• Monitor and support QC compliance with electronic systems and computerized laboratory applications.
• Support periodic review of electronic records and audit trails.
• Support inspection and audit readiness activities within QC.
• Participate in internal, customer, and regulatory audits/inspections.
• Assist in preparing responses to audit observations and information requests.
• Serve as a QC Data Integrity and Compliance (DICO) Champion.
• Perform analytical testing and sampling of materials.
• Maintain proper documentation according to cGMP and GDP.
• Understand 21 CFR Part 11 requirements.

Skills

Critical thinking

Customer service

Data integrity

Analytical data

Electronic lab systems

Audit readiness

Communication skills

Data interpretation

Education

Bachelor's degree in science

Associate's degree in science

Tools

GC

HPLC

UV/Vis

IR

Potentiometer

Refractometer

Karl Fischer

Density meter

Oven

Job description

Piramal Critical Care (PCC) is seeking a Senior Quality Control Analyst to perform testing on in-process materials, bulk drug substances, and finished drug products, while ensuring CGMP/GDP compliance. The role supports electronic systems, audit trails, and inspection readiness across QA functions.

The ideal candidate has 3+ years of QC experience in pharma, strong data integrity skills, and familiarity with regulatory expectations, contributing to timely audit responses and continuous