Senior GDP Compliance Specialist, Supply Chain

Advanced Bio-Logic Solutions Corp; Louisville (KY); Híbrido; USD 36.000 - 41.000; A tiempo parcial

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

Descripción de la vacante

Advanced Bio-Logic Solutions Corp is hiring a Sr Associate Supply Chain Compliance to support GDP compliance across US supply chains. You will own quality records, deviations, temperature excursions, and CAPA processes, collaborating with QA, supply chain, and IS teams.

The role is hybrid with 3 days onsite and interaction with internal and external stakeholders. Required are 2+ years in GMP/GDP (or 4+ years without a life sciences degree), strong QA/GMP/GDP knowledge, and proficiency with

Formación

• Bachelor’s degree in Life Sciences (or equivalent) with 2+ years of GMP/GDP compliance experience, or 4+ years in GMP/GDP without Life Sciences degree.
• Solid knowledge of QA, GMP and GDP.
• Analytical, evidence-based problem solving and strong documentation skills (technical writing).
• Experience with Smartsheet, Excel, PowerPoint, and TrackWise; familiarity with EDMQ is a plus.
• Strong cross-functional collaboration and communication skills.

Responsabilidades

• Embed GDP in the US supply chain to maintain product quality.
• Own and manage temperature excursions and deviation records.
• Lead root-cause analysis for deviations of all severities.
• Own CAPA and CAPA EV records and ensure implementation.
• Support audits and inspections; manage missing product notifications.
• Maintain up-to-date records in Smartsheets for deviations and related items.
• Contribute to continuous improvement initiatives and risk-based decision making.

Conocimientos

Quality Assurance

GMP

GDP

Educación

Bachelor’s degree in Life Sciences

Herramientas

Smartsheet

Excel

PowerPoint

TrackWise

EDMQ

Descripción del empleo

Advanced Bio-Logic Solutions Corp is hiring a Sr Associate Supply Chain Compliance to support GDP compliance across US supply chains. You will own quality records, deviations, temperature excursions, and CAPA processes, collaborating with QA, supply chain, and IS teams.

The role is hybrid with 3 days onsite and interaction with internal and external stakeholders. Required are 2+ years in GMP/GDP (or 4+ years without a life sciences degree), strong QA/GMP/GDP knowledge, and proficiency with