Supply Chain Quality Analyst

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet in Raleigh, NC is seeking a Supply Chain Quality Analyst to ensure batch release readiness in a GDP/cGMP environment, review records, and coordinate with QC, QA, Manufacturing and Logistics.

You will monitor release KPIs, drive CAPA-based improvements, and maintain 21 CFR Part 11 compliance, while updating SOPs and supporting training across teams.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or equivalent.
• 3+ years’ experience in pharmaceutical batch release or quality systems at a cGMP/GDP site.
• Experience facilitating inbound raw material release and finished goods batch release.
• Strong knowledge of FDA 21 CFR 210/211, 21 CFR Part 11, and EU GDP requirements.
• Proficient in cross-functional communication, deviation escalation, and CAPA systems.
• Familiarity with ERP/WMS documentation management and electronic quality systems.

Responsibilities

• Owns end-to-end batch release lifecycle: inbound raw materials, intermediates, and finished goods—reviewing batch records, Certificates of Analysis, and ensuring alignment with cGMP and GDP requirements.
• Coordinates cross-functionally (QC, QA, Manufacturing, Logistics) to resolve hold-ups, reconcile discrepancies, and communicate release status to stakeholders.
• Monitors batch release KPIs (e.g., release cycle time, documentation completeness, hold-to-release ratio); drives process improvements using CAPA methodology and procedural optimization.
• Facilitates GMP alignment at the warehouse–production boundary (label control, status segregation, quarantine, FEFO/traceability)
• Escalates nonconformances and deviations impacting release timelines, initiates investigations according to SOPs.
• Ensures strict compliance with data integrity (ALCOA+), maintaining electronic and paper records per 21 CFR Part 11, GDP, and internal Quality Systems.
• Reviews and updates SOPs/WIs related to batch release and material inbound quality release; supports training and competency assessments across teams.
• Performs ad-hoc quality checks (e.g., QC results, GMP documentation) and collaborates on material review board/QA disposition meetings.
• Ensures timely release of inbound raw material and excipient batches to prevent downstream manufacturing delays, coordinates laboratory escalation and deficiency resolution.
• Performs other duties as assigned by management.

Skills

Cross-functional collaboration

Deviations handling

CAPA management

Data integrity

Education

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or equivalent

Tools

ERP/WMS documentation management

Electronic quality systems

Job description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The Supply Chain Quality Analyst will operate in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

Leads coordination and execution of inbound raw material and finished goods batch release processes in a GDP/cGMP environment. Ensures clear tracking of release steps, timely documentation, and operational integrity across Supply Chain, QC, QA, and Manufacturing. Restores batch release compliance and maintains site inspection readiness.

YOUR ROLE

• Owns end-to-end batch release lifecycle: inbound raw materials, intermediates, and finished goods—reviewing batch records, Certificates of Analysis, and ensuring alignment with cGMP and GDP requirements.
• Coordinates cross-functionally (QC, QA, Manufacturing, Logistics) to resolve hold-ups, reconcile discrepancies, and communicate release status to stakeholders.
• Monitors batch release KPIs (e.g., release cycle time, documentation completeness, hold-to-release ratio); drives process improvements using CAPA methodology and procedural optimization.
• Facilitates GMP alignment at the warehouse–production boundary (label control, status segregation, quarantine, FEFO/traceability)
• Escalates nonconformances and deviations impacting release timelines, initiates investigations according to SOPs.
• Ensures strict compliance with data integrity (ALCOA+), maintaining electronic and paper records per 21 CFR Part 11, GDP, and internal Quality Systems.
• Reviews and updates SOPs/WIs related to batch release and material inbound quality release; supports training and competency assessments across teams.
• Performs ad-hoc quality checks (e.g., QC results, GMP documentation) and collaborates on material review board/QA disposition meetings.
• Ensures timely release of inbound raw material and excipient batches to prevent downstream manufacturing delays, coordinates laboratory escalation and deficiency resolution.
• Performs other duties as assigned by management.

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or equivalent.
• 3+ years’ experience in pharmaceutical batch release or quality systems within a cGMP/GDP-regulated site.
• Proven experience facilitating inbound raw material release and finished goods batch release processes.
• Strong knowledge of FDA 21 CFR 210/211, 21 CFR Part 11, and EU GDP requirements.
• Proficient in managing cross-functional communication, deviation escalation, and deviation/CAPA systems.
• Familiarity with ERP/WMS documentation management and electronic quality systems.

Preferred Qualifications

• APICS certification, Lean/Six Sigma experience.
• Record of leading QA projects, batch release continuous improvement, or metric-driven performance programs.