Dynamic Quality Compliance Specialist - GMP, Audits & QMS

Koch Business Solutions, LP; Hudson (WI); Presencial; USD 80.000 - 105.000; Jornada completa

Descripción de la vacante

Phillips Medisize, a Molex company, is seeking a Quality Compliance Specialist to support the divisional Quality Compliance team. The role focuses on enhancing compliance and quality standards across sites, managing audits, and ensuring regulatory adherence in a dynamic environment.

It is an onsite position based out of Hudson, New Richmond, or Menomonie. As a key member of the Quality Assurance group, you will lead CAPAs, change controls, QMS activities, and data-driven improvement initiatives

Formación

• Bachelor's degree or 5+ years of QA in a regulated industry.
• Experience with cGMP manufacturing and QA practices.
• Strong understanding of FDA, ISO, and GMP requirements.
• Experience with data analysis and reporting tools (Excel, PowerPoint, Power BI).

Responsabilidades

• Ensure compliance with GMP and relevant regulations across multiple sites.
• Lead investigations, CAPAs, and change control processes.
• Act as a subject matter expert on quality topics, advising on policies and compliance decisions.
• Manage internal and external audits, and host regulatory inspections.
• Collaborate with teams to address audit findings and enhance compliance.
• Conduct gap assessments and recommend strategies for regulatory compliance.
• Support and manage Quality Management System (QMS) processes.
• Deliver training programs to enhance compliance with QMS requirements.
• Drive quality improvement projects using data analytics to identify trends.
• Travel 10% - 20% for audits and compliance activities.

Conocimientos

Regulatory knowledge

Quality assurance

Data analysis

Auditing

Educación

Bachelor's degree in quality management, Chemistry, Microbiology, Regulatory Affairs, or related field

5+ years QA experience in a regulated industry

Herramientas

Excel

Power BI

PowerPoint

Descripción del empleo

Phillips Medisize, a Molex company, is seeking a Quality Compliance Specialist to support the divisional Quality Compliance team. The role focuses on enhancing compliance and quality standards across sites, managing audits, and ensuring regulatory adherence in a dynamic environment.

It is an onsite position based out of Hudson, New Richmond, or Menomonie. As a key member of the Quality Assurance group, you will lead CAPAs, change controls, QMS activities, and data-driven improvement initiatives