Senior QC Compliance Scientist – cGMP & Data Integrity

RXinsider LTD.; New Jersey; Hybrid; USD 114,000 - 178,000; Full time

Benefits offered by this job

Health benefits

401(k) plan with match

Paid time off

Job summary

Quva seeks a Principal Scientist, QC Compliance in Bloomsbury, NJ. This senior role leads laboratory compliance, data integrity, and performance across analytical chemistry and microbiology, partnering with QA, Manufacturing, and Regulatory Affairs to strengthen quality systems and inspection readiness.

You will own CAPAs, oversee investigations, drive continuous improvement, and mentor QC scientists while ensuring cGMP/GDP regulatory alignment.

Qualifications

• Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field.
• Master’s or PhD preferred.
• 10+ years of experience in pharmaceutical QC, QA, or compliance within a cGMP environment.
• Experience with method validation and investigations.
• Authorized to work in the United States; no visa sponsorship.

Responsibilities

• Serve as SME for QC compliance across analytical chemistry and microbiology labs.
• Ensure all QC activities meet cGMP, GDP, SOPs and regulatory requirements.
• Oversee lab equipment lifecycle, validation, and data integrity standards.
• Lead initiatives to improve compliance, inspection readiness, and audits.
• Maintain QC dashboards and KPIs, driving corrective actions.

Skills

cGMP expertise

GDP expertise

Regulatory inspections

Data integrity

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field

Master’s or PhD preferred

Tools

LIMS/Empower

JMP

Minitab

Job description

Quva seeks a Principal Scientist, QC Compliance in Bloomsbury, NJ. This senior role leads laboratory compliance, data integrity, and performance across analytical chemistry and microbiology, partnering with QA, Manufacturing, and Regulatory Affairs to strengthen quality systems and inspection readiness.

You will own CAPAs, oversee investigations, drive continuous improvement, and mentor QC scientists while ensuring cGMP/GDP regulatory alignment.