Sr. Quality Compliance Engineer

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 Sr.

Quality Compliance Engineer to join our Specialty Additives business at our Hopewell, VA site.

This is a very visible, significant role within the Company and the Quality and Regulatory function.

This position will report to the Quality Systems Manager.

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


* Responds to compendial/regulatory issues


* Raw material supplier qualification and spec.

development, specification, reviewer


* Validation / Qualification advisor


* GMP coordinator and auditor


* Regulatory audit liaison – FDA, Kosher, Halal, etc.


* Quality Batch Record Review


* Stability program owner (samples, testing, monitoring, letters)


* Facilitate site Quality Risk Assessments


* Investigate and respond to customer complaints


* Initiates and oversees out-of-spec investigations where appropriate


* Participates in Quality, Safety and Environmental initiatives that will contribute to compliance of State/Federal regulations and improve existing Company programs.

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


* Bachelor's Degree



* Minimum of 10 years of quality assurance experience in a manufacturing environment.


* Knowledgeable in quality assurance systems, statistical quality control & procedures, chemical plant processes, cGMP guidelines & regulations, and ISO-9001:2015 standards.

The following skills sets are preferred by the business unit:


* Understanding of Food Safety, EFfCI, and EXCiPACT standards.


* Minimum of 2 years of regulatory experience in a manufacturing environment.


* Experience with Quality Risk Management, Change management, HACCP and excipient regulations (IPEC)


* Experience in leading and organizing internal and external audits

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....