QA Specialist – GMP, ISO 9001 & Quality Systems

Ashland Inc.; Wilmington, Northern (DE, KY); Hybrid; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Ashland Inc. is seeking a QA Specialist to join the Life Sciences, Quality and Regulatory team at the Wilmington Aquarius facility. The role emphasizes maintaining and improving quality systems and regulatory compliance.

The position reports to the Quality Manager and works with laboratory, manufacturing, regulatory, and supply chain teams to ensure product quality and drive continuous improvement.

Qualifikationen

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

Aufgaben

• Maintain and continuously improve site quality procedures and the quality management system.
• Support compliance with ISO 9001, 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 (SOPs, work instructions, DMFs).
• Conduct internal quality and cGMP audits, gap assessments, and compliance reviews.
• Perform risk assessments to identify potential hazards, evaluate compliance risks, and implement controls.
• Investigate deviations, out-of-spec results and customer complaints; identify root causes and corrective actions.
• Review batch records and release activities in iLIMS and SAP.
• Manage product stability programs and coordinate retesting as required.
• Provide regulatory intelligence and documentation support for site products and initiatives.

Kenntnisse

Communication

Teamwork

Quality mindset

Documentation

Ausbildung

BS in chemistry or biology

Tools

SAP

iLIMS

Microsoft Office

Jobbeschreibung

Ashland Inc. is seeking a QA Specialist to join the Life Sciences, Quality and Regulatory team at the Wilmington Aquarius facility. The role emphasizes maintaining and improving quality systems and regulatory compliance.

The position reports to the Quality Manager and works with laboratory, manufacturing, regulatory, and supply chain teams to ensure product quality and drive continuous improvement.