Quality Assurance Specialist — GMP & Compliance

Ashland Specialty Ingredients, GP; Wilmington (DE); Presencial; USD 80.000 - 110.000; Jornada completa

Descripción de la vacante

Ashland Specialty Ingredients, GP invites a QA Specialist to join the Life Sciences, Quality and Regulatory team at the Wilmington site. This role reports to the Quality Manager and is pivotal for maintaining and improving quality systems, SOPs, and regulatory documentation.

The candidate will conduct internal audits, manage documentation, and ensure data integrity across iLIMS and SAP, while collaborating with manufacturing, regulatory, and supply chain teams to uphold the highest quality

Formación

• BS in chemistry or biology or equivalent years of experience.
• 5–8 years Quality Assurance experience in a regulated industry.
• Strong written and oral communication skills with ability to read, interpret, and report data.
• Competency in Microsoft Office Suite.
• Experience with SAP and iLIMS.
• Knowledge of Laboratory cGMP, GLP and Safety.

Responsabilidades

• Maintain and continuously improve site quality procedures and the quality management system.
• Support compliance with ISO 9001, current Good Manufacturing Practices (cGMP), and applicable site quality standards.
• Maintain accurate, controlled, and audit-ready quality documents in accordance with good documentation practices.
• Promote data integrity and uphold ethical standards in testing, research, and reporting.
• Prepare, update, and maintain quality and regulatory documentation, including SOPs, work instructions, and Drug Master File support documents.
• Conduct internal quality and cGMP audits, gap assessments, and compliance reviews.
• Perform risk assessments to identify potential hazards, evaluate compliance risks, and implement appropriate controls.
• Investigate deviations, out-of-specification results, and customer complaints; identify root causes and recommend corrective actions.
• Support management of change activities and quality-related validation projects.
• Conduct supplier risk assessments and support supplier qualification and approval activities.
• Evaluate raw materials for quality and regulatory compliance.
• Review batch records and complete final product release activities in iLIMS and SAP.
• Manage the product stability program, including sample coordination, data review, and documentation.
• Coordinate raw-material and finished-product retesting as required.
• Review product compliance against applicable compendial and global monograph requirements.
• Maintain records and coordinate submissions for new Halal and Kosher product certifications.
• Provide regulatory intelligence and documentation support for site products and initiatives.
• Respond promptly and accurately to quality- and regulatory-related customer inquiries and documentation requests.
• Set up new products in iLIMS and maintain accurate product master data.
• Support qualification of new laboratory equipment and associated documentation.
• Provide backup support to the Quality Control laboratory and inspect samples to verify consistent product quality.
• Monitor quality metrics, analyze trends, and communicate findings to support informed decision-making.
• Identify potential sources of error and recommend practical improvements to strengthen quality, reliability, and efficiency.
• Collaborate cross-functionally with laboratory, manufacturing, regulatory, supply chain, and other site teams.
• Support quality and Environmental, Health, and Safety good-catch programs and related improvement initiatives.

Conocimientos

Quality Assurance

cGMP

Data integrity

Documentation

Communication

Educación

BS in chemistry or biology

Herramientas

SAP

iLIMS

Descripción del empleo

Ashland Specialty Ingredients, GP invites a QA Specialist to join the Life Sciences, Quality and Regulatory team at the Wilmington site. This role reports to the Quality Manager and is pivotal for maintaining and improving quality systems, SOPs, and regulatory documentation.

The candidate will conduct internal audits, manage documentation, and ensure data integrity across iLIMS and SAP, while collaborating with manufacturing, regulatory, and supply chain teams to uphold the highest quality