Senior QC Compliance Scientist, cGMP & Audits

Quva

Bloomsbury (NJ)

On-site

USD 114,000 - 178,000

Full time

11 days ago

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Benefits offered by this job

Health, dental, vision benefits

401k with company match

Paid time off and holidays

Job summary

Quva is seeking a Principal Scientist, QC Compliance on-site in Bloomsbury, NJ. You will provide senior technical leadership across analytical chemistry and microbiology to ensure cGMP and GDP compliance, data integrity, and inspection readiness.

This role partners with QA, Manufacturing, and Regulatory Affairs to strengthen quality systems and drive continuous improvement. You will oversee investigations, CAPA effectiveness, and dashboard KPIs, while mentoring QC scientists and analysts in

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-regulated environment.
Significant experience in analytical and/or microbiology laboratory operations.
Demonstrated leadership in regulatory inspections, audits, and compliance remediation.
Experience with method validation, stability programs, and lab investigations required.

Responsibilities

Serve as SME for QC compliance across analytical chemistry and microbiology laboratories.
Ensure QC activities meet cGMP, GDP, SOPs, and regulatory requirements.
Oversee lab equipment lifecycle management, computer system validation, and data integrity standards.
Lead initiatives to improve compliance frameworks, inspection readiness, and audit outcomes.
Own and monitor QC dashboards and KPIs, and perform trend analyses of lab events and investigations.
Lead complex lab investigations (OOS, OOT, deviations, customer inquiries) with timely, compliant resolutions.
Identify recurring issues and implement robust CAPAs to prevent recurrence.