QA Specialist

Ashland Specialty Ingredients, GP; Wilmington (DE); On-site; USD 80,000 - 110,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

cGMP

Data integrity

Documentation

Communication

Education

BS in chemistry or biology

Tools

SAP

iLIMS

Job description

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

• 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 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.

Qualifications

• BS in chemistry or biology or equivalent years of experience.
• At least 5 to 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.

In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer. At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do. Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty. Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit. Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.

Infinite possibilities Creating good chemistry isn’t just about what happens when you add the right ingredients together. It’s about what happens when the right people are one of the ingredients. Good chemistry – the kind that can transform a market or a world – is what makes Ashland different and what makes us better. If you’re passionate about the infinite possibilities created through good chemistry, we have a rewarding and challenging opportunity for you to help us make great things happen every day for our customers, our communities, our investors and our colleagues around the world.