Supply Chain Quality Analyst

Guerbet; Raleigh (NC); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Guerbet is seeking a Supply Chain Quality Analyst to own batch release activities in a GDP/cGMP environment, ensuring timely release of inbound materials and finished goods.

You will coordinate with QC, QA, Manufacturing, and Logistics, monitor batch-release KPIs, and drive CAPA-driven improvements while upholding 21 CFR Part 11 data integrity and compliant documentation. This role offers growth in a global, collaborative setting.

Qualifications

• Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Chemistry, Engineering.
• 3+ years’ experience in pharmaceutical batch release or quality systems on a cGMP/GDP 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 cross-functional communication, deviation escalation, and deviation/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.

Skills

Cross-functional communication

Deviation escalation

CAPA systems

ERP / WMS documentation

Electronic quality systems

Education

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

Tools

ERP software

Quality management software

Job description

Supply Chain Quality Analyst

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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

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.

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]