Supply Chain Quality Analyst

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.

Role

• Owes 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.
• Cross-functionally coordinates to resolve hold-ups, reconcile discrepancies, and communicate release status to stakeholders.
• Maintains 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.

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

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 horizons.

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 provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717.