Quality Specialist

Ashland Inc. • Calvert City, KY

3d • Onsite

About The Position

Ashland has an opportunity for a Quality Specialist to join its ISP Chemicals LLC business at the Calvert City, Kentucky facility. This is a visible role within the Company’s Quality function and reports to the Quality Systems Manager. It is an individual-contributor position with no direct reports. The work is not solely office-based; it includes time in production and warehousing areas auditing and reviewing documentation where it is generated.

The role focuses on daily audits of regulated production-area documentation and batch-packet reviews to ensure regulatory and cGMP requirements are met. It also tracks and reports product-failure investigations, off-standard product inventory, and inventory approaching its retest date. The position supports investigations, document and procedure changes, internal audits, food safety activities, and continuous improvement across quality and manufacturing.

Requirements

• Bachelor of Science or Business degree, or four years of Quality Assurance experience in a regulated chemical or related industry.
• Strong computer skills, including experience with ERP, LIMS, CRM, Microsoft Office (Word, Excel, Outlook, and PowerPoint), and SharePoint.
• Strong organizational skills and attention to detail.
• Strong written and verbal communication skills and the ability to interface with people at all levels.
• Ability to wear appropriate PPE in plant and laboratory environments, which may include a hard hat, safety glasses, ear plugs, steel-toed shoes, gloves, lab coat, FR clothing, or other equipment required for the work.
• Ability to travel and work within production, laboratory, and warehousing areas to perform daily activities.
• Ability to perform physical activities that may include walking, climbing stairs, bending, stooping, kneeling, or reaching, depending on the work activity.
• Demonstrated responsible and ethical behavior.
• Ability to help the company drive value by understanding the business, making complex decisions, and creating new and different approaches.

Nice To Haves

• ISO/GMP internal auditor certification.
• Administrative experience.

Responsibilities

• Conduct daily audits of regulated production-area documentation and review batch packets for regulatory and cGMP compliance.
• Ensure cGMP batch-record requirements and documentation of production operations are met daily.
• Review batch records against approved written operating procedures, ensuring process deviations are documented and followed through to product disposition.
• Review warehouse product-regrade paperwork for cGMP compliance.
• Review processes and procedures for compliance with regulations and guidelines.
• Support quality and manufacturing teams on out-of-specification investigations by defining investigative strategy, approving and tracking investigations, reviewing trends, and facilitating completion.
• Maintain the off-standard product summary and facilitate routine reviews with production management.
• Monitor site-produced inventory nearing shelf-life or retest dates and facilitate necessary retesting and product extensions.
• Facilitate changes to related SOPs, policies, training materials, and other documents.
• Support selected large-scope projects through data collection and research, and research smaller topics and draft recommendations for quality management.
• Collaborate with the quality team and other groups on root-cause analyses, problem resolution, and continual improvement.
• Act as an internal ISO/GMP auditor and serve as a food safety team member.
• Apply working knowledge of good documentation practices (GDP).
• Contribute to organizational goals by taking initiative, executing goals, and focusing on performance and safety.
• Build collaborative relationships, optimize diverse talent, and use positive communication and influence to improve organizational capacity and capabilities.

Benefits

• Comprehensive medical, dental, and vision benefits for the employee and family starting on Day 1.
• 401(k) plan with company match.
• Industry-competitive salary and pay-for-performance incentive plans.
• Diverse work environment and opportunities for development and advancement throughout the global organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level