Quality Specialist

Ashland; Calvert City (KY); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Comprehensive Benefit package

401(k) plan with company match

Job summary

ISP Chemicals LLC in Calvert City, KY seeks a Quality Specialist to join our production site quality team. The role focuses on daily audits of regulated production area documentation, batch review processes, and cGMP compliance.

You will support investigations, manage off‑standard inventory, and help drive improvements with cross‑functional teams. The ideal candidate has a BS/BA or 4+ years in QA within regulated chemical environments, strong computer skills across ERP, LIMS, CRM and MS Office,

Qualifications

• Bachelor or equivalent with 4 years+ QA experience in regulated chemical or related industry.
• Strong computer skills with ERP, LIMS, CRM and MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint.
• Organizational skills and attention to detail; ability to interface with all levels with strong written and verbal skills.
• Ability to wear PPE in plant and lab environments; willingness to work/travel within production, lab and warehouse areas.

Responsibilities

• Conduct daily audits of production area documentation and perform batch packet reviews to ensure regulatory and cGMP compliance.
• Track and report on product failure investigations and inventory status of off‑standard products.
• Review batch records against approved SOPs and ensure deviations are documented and dispositioned.
• Monitor inventory nearing shelf life or retest date and coordinate retesting actions.
• Support investigations and root‑cause analyses; facilitate completion and improvements.
• Assist with SOP, policy, training material updates and cross‑functional quality initiatives.

Skills

Communication skills

Organizational skills

Education

Bachelor of Science or Business Degree

Tools

ERP

LIMS

CRM

Microsoft Office

SharePoint

Job description

ISP Chemicals LLC

Quality Specialist - Calvert City, Kentucky

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 Quality Specialist to join our ISP Chemicals LLC business at our Calvert City, Kentucky facility. This is a very visible, significant role within the Company and the Quality function. This position will report to the Quality Systems Manager.

The responsibilities of the position include, but are not limited to, the following:

• The primary role of this position is to conduct daily audits of the regulated production area documentation and perform batch packet reviews to ensure that regulatory and cGMP requirements are met. Additionally, this position is responsible for tracking and reporting on product failure investigations, inventory status of off standard product, and monitoring and determining next steps for inventory nearing retest date.
• Ensure compliance with batch record requirements and documentation of production operations on cGMP product daily.
• Review batch records to approved, written operating procedures to ensure that any deviation from the process is documented and followed through with product disposition.
• Review warehouse product regrade paperwork for cGMP compliance.
• Review processes and procedures for compliance with regulations and guidelines.
• Support quality/manufacturing in out of spec investigations (OOSI's) by defining investigational strategy, approving, tracking trends, and facilitating the flow through to completion
• Maintain off-standard product summary and facilitate routine review with production management.
• Monitor company inventory for site-produced material nearing shelf life/retest date. Facilitate actions necessary for material retesting and product extensions.
• Facilitate changes to related SOPs, policies, training materials, and other documents.
• Provide support on selected, large-scope projects involving data collection and / or research small scope individual topics drafting recommendations to quality management.
• Work with other Ashland solvers on the quality team. Interface with other groups in root-cause analyses, problem resolution, and continual improvement.
• Acting internal ISO/GMP auditor and food safety team member
• Working knowledge of good documentation practices (GDP)
• Actively contribute to the organizational goals by taking initiative, executing on goals and focusing on performance and safety.
• Improve the organization capacity and capabilities through building collaborative relationships, optimizing diverse talent and utilizing positive communications and influence with others.

What This Role Is Not:

• Not a management position - while you will collaborate with other team members, this is an individual contributor role with no direct reports
• Not just an office-based role - You will spend time in the production and warehousing areas, auditing and reviewing documentation at its generation points.

In order to be qualified for this role, you must possess the following:

• Bachelor of Science or Business Degree or 4 years' experience in Quality Assurance in a regulated chemical or related industry.
• Strong computer skills with experience in ERP, LIMS, CRM and other global business applications such as Microsoft Office (Word, Excel, Outlook, PowerPoint) and SharePoint.
• Organizational skills and attention to detail.
• Capable of interfacing with others at all levels with strong written and verbal skills.
• Ability to wear appropriate PPE within the plant and laboratory environments, which may include: hard hat, safety glasses, ear plugs, steel-toed shoes, gloves, lab coat, FR clothing, or other equipment required by the work performed.
• Must be able to work/travel within the production facility, laboratory, and warehousing areas to perform daily activities.
• Physical activities may include walking, climbing stairs, bending, stooping, kneeling, or reaching depending on the work activity required.
• Demonstrated responsible and ethical behavior at all times
• The ability to help the company drive greater value through understanding the business, making complex decisions and creating the new and different

The following skill sets are preferred by the business unit:

• ISO/GMP internal auditor certification
• Administrative experience

Perks of working at Ashland:

• Comprehensive Benefit package, Medical, Dental and Vision starting on Day 1 for you AND your family
• 401(k) plan with company match

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 solut