Analytical Validation & Stability Lead, QC

Kelly Science, Engineering, Technology & Telecom

Raleigh (NC)

On-site

USD 120,000 - 160,000

Full time

3 days ago

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Job summary

Unknown QC team is seeking a QC LCM / Stability Lead to provide technical leadership for analytical method validation, stability programs, and analytical lifecycle management in a cGMP pharmaceutical environment.

The role serves as SME for validation strategy, stability studies, regulatory compliance, and inspection readiness while leading scientists and collaborating with cross-functional teams to support commercial products and lifecycle activities.

Qualifications

Bachelor's degree with 10+ years of pharmaceutical analytical laboratory experience, or Master's with 5+ years, or PhD with 2+ years.
Extensive experience with analytical method validation in a cGMP pharmaceutical environment.
Strong knowledge of ICH guidelines (Q2, Q1A), USP requirements, and cGMP regulations.
Experience with HPLC, GC, dissolution, spectroscopy, and other analytical techniques.
Experience with Empower, LIMS, or other chromatography data systems.
Strong troubleshooting, investigation, and root cause analysis skills.
Excellent written, verbal, and cross-functional communication skills.

Responsibilities

Lead analytical method validation, verification, transfer, and lifecycle management activities.
Develop and oversee validation strategies in alignment with cGMP, ICH, USP, and regulatory expectations.
Review and approve validation protocols, reports, and technical documentation.
Serve as SME during FDA and other regulatory inspections and customer audits.
Lead investigations involving OOS, OOT, deviations, and method-related quality issues, including root cause analysis and CAPA implementation.
Oversee stability programs and ensure compliance with stability protocols and reporting requirements.
Drive continuous improvement initiatives for analytical methods, laboratory processes, and validation programs.
Ensure laboratory instrumentation, systems, and documentation remain qualified, compliant, and audit ready.
Partner with Quality, Regulatory Affairs, Manufacturing, and R&D to support product development, submissions, and commercial operations.
Mentor and develop scientists and analysts while promoting a strong quality and compliance culture.
Maintain compliance with cGMP, ALCOA+ data integrity principles, and global regulatory requirements.