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 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 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.