Job Details

Quality Specialist

Ashland has an exciting opportunity for a Quality Specialist to join our ISP Chemicals LLC business in Columbus, OH. This is a very visible, significant role within the Company and the Quality function. The position will report to the Quality Systems Manager.

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

• Perform and assist with Quality Assurance activities, including internal, customer, and regulatory audits.
• Investigate and respond to customer complaints.
• Quality batch record reviews.
• Initiates out-of-spec investigations where appropriate.
• Support production by performing or participating in root cause investigations and pulling and trending historical data.
• Participate in Quality Risk Assessments.
• Participate in process improvements and the implementation of new quality systems.
• Provide sales, customer service, and business management support by answering and assisting with customer requests and inquiries.
• Assist in cultivating a quality culture through participation in cross-functional teams.
• Participates in quality, safety, and environmental initiatives that will contribute to compliance with State/Federal regulations and improve existing programs.
• Assign appropriate usage decision codes in SAP to aid supply chain with inventory control.

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

• Bachelor's degree in chemistry, biology, chemical engineering, or related scientific fields.
• 1 - 3 years experience in a GMP chemical manufacturing environment or related industry.
• Knowledge and experience with GMP associated with manufacturing APIs and excipients (ICH Q7 and IPEC/EXCiPACT specifically).
• Ability to read, understand, and execute procedures and process instructions.
• Ability to read and understand required standards and translate them to site procedures.
• Ability to receive safety and process training.
• Ability to participate and contribute to zero-incident culture and the facility's safety and quality culture to maintain and improve the safety of employees and products.
• Strong attention to detail and data analysis skills.
• Ability to effectively categorize quality complaints and lead incidents to closure.
• Excellent communication skills.
• Strong organizational and documentation skills and attention to detail.
• Ability to thrive in a multinational and multicultural environment.
• Must be authorized to work in the US.

The following skill sets are preferred by the business unit:

• Strong knowledge of FDA cGMP operations, requirements, and safety programs.
• Familiarity with SAP or similar ERP systems.
• Proficient knowledge of ICH/FDA and ISO requirements, as well as IPEC/EXCiPACT guidelines and standards.
• Strong computer skills; Microsoft Office applications & iLIMS or similar Quality database.