Quality Specialist

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 tale...