Quality Assurance Auditor – cGMP & ISO Focus

Ashland Inc.; Calvert City (KY); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Comprehensive Benefit package

401(k) plan

Job summary

Ashland is seeking a Quality Specialist for ISP Chemicals LLC in Calvert City, KY. You will conduct daily audits of production area documentation and review batch records to ensure cGMP compliance, supporting investigations and inventory controls. The role requires collaboration with quality and manufacturing teams and may involve ISO/GMP audits and food safety activities.

PPE and site travel are expected. The position emphasizes accuracy, regulatory alignment, and continuous improvement within

Qualifications

• 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 PPE in plant and lab environments and work/travel within facility areas.
• Demonstrated responsible and ethical behavior and ability to contribute to value through smart decisions.

Responsibilities

• Audit daily production area documentation and perform batch packet reviews to ensure cGMP compliance.
• Track product failures, inventory nearing shelf life, and retest dates.
• Review batch records against approved SOPs and document deviations.
• Support OOSI investigations with data and trends; facilitate completion.
• Maintain off-standard product summaries and coordinate with production management.
• Assist with SOP changes, policies, and training materials.
• Collaborate with quality and manufacturing teams on root cause analyses and improvements.
• Act as internal ISO/GMP auditor and food safety team member.

Skills

Attention to detail

Strong written and verbal skills

Interpersonal collaboration

PPE compliance

Education

Bachelor of Science or Business Degree or 4 years’ experience in Quality Assurance

Tools

ERP

LIMS

CRM

Microsoft Office

SharePoint

Job description

Ashland is seeking a Quality Specialist for ISP Chemicals LLC in Calvert City, KY. You will conduct daily audits of production area documentation and review batch records to ensure cGMP compliance, supporting investigations and inventory controls. The role requires collaboration with quality and manufacturing teams and may involve ISO/GMP audits and food safety activities.

PPE and site travel are expected. The position emphasizes accuracy, regulatory alignment, and continuous improvement within