QA Specialist

Ashland Specialty Ingredients, GP

Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?

Are you always solving?

Then we'd like to meet you and bet you'd like to meet us.

Ashland has an exciting opportunity for a QA specialist to join our Life Sciences, Quality and regulatory team Ashland Specialty ingredients G.P.

business at our Wilmington aquarius manufacturing location.

This is a very visible, significant role within the Company and the Quality and Regulatory function.

This position will report to Quality Manager on the site.

Key responsibilities include, but are not limited to:


* 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 Standard Operating Procedures (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 C...