Quality Compliance Lead - GMP & Audits (Onsite)

Koch Business Solutions, LP; Menomonie (WI); Vor Ort; USD 90.000 - 110.000; Vollzeit

Zusammenfassung

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to strengthen the divisional Quality Compliance team. The role focuses on audits, QMS oversight, and regulatory adherence across sites, driving continuous improvement and a culture of excellence.

The position is onsite in Hudson, New Richmond, or Menomonie, with 10–20% travel for audits and compliance activities. A strong background in FDA/ISO/GMP and data analysis is required to support quality initiatives and training.

Qualifikationen

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

Aufgaben

• Ensure GMP compliance across multiple sites.
• Lead investigations, CAPAs and change controls.
• Act as SME on quality topics and compliance decisions.
• Manage internal and external audits and host regulatory inspections.
• Collaborate to address audit findings and enhance compliance.
• Conduct gap assessments and regulatory strategy.
• Support QMS processes and deliver training on QMS requirements.
• Drive quality improvement projects using data analytics.
• Travel 10–20% for audits and compliance activities.

Kenntnisse

GMP compliance

Regulatory knowledge

Data analysis

Auditing

Ausbildung

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

5+ years QA in regulated industry

Tools

Excel

PowerPoint

Power BI

Jobbeschreibung

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to strengthen the divisional Quality Compliance team. The role focuses on audits, QMS oversight, and regulatory adherence across sites, driving continuous improvement and a culture of excellence.

The position is onsite in Hudson, New Richmond, or Menomonie, with 10–20% travel for audits and compliance activities. A strong background in FDA/ISO/GMP and data analysis is required to support quality initiatives and training.