Quality Process Specialist: CAPA, ADPR & Lean

Trustapexinternational; Eden Prairie (MN); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical benefits

Disability insurance

Life insurance

Optional life insurance

FSA options

401(k) match

Employee assistance program

Job summary

Apex International is seeking a detail-oriented Quality Process Specialist to join our Quality team in Eden Prairie, MN. You will lead quality event investigations, CAPA management, and ADPR activities to ensure regulatory compliance and customer satisfaction.

You will support quality systems, lean initiatives, and cross-functional projects across Manufacturing, Quality Control, and R&D teams. A 1–3+ year background in cGMP environments and a relevant bachelor's degree are preferred.

Qualifications

• 1-3+ years in a Quality role within a cGMP manufacturing environment preferred.
• Bachelor's degree in Quality Assurance, Biology, Chemistry, or related scientific discipline preferred; equivalent education/experience considered.

Responsibilities

• Lead quality event investigations and CAPA management to address root causes.
• Manage Annual Drug Product Review (ADPR) processes and regulatory compliance.
• Support quality systems and continuous improvement initiatives.
• Assist Apex Quality Audit Program including internal/audits and corrective actions.
• Promote lean action culture and 5S in the department.
• Collaborate with Manufacturing, Quality Control, R&D and Customer teams on quality initiatives.
• Other duties as assigned.

Skills

Root cause analysis

Investigations

CAPA management

Audits

Quality systems

Data analysis

Documentation

Lean principles

Cross-functional collaboration

Education

Bachelor's degree in QA/biology/chemistry

Tools

Microsoft Office

Job description

Apex International is seeking a detail-oriented Quality Process Specialist to join our Quality team in Eden Prairie, MN. You will lead quality event investigations, CAPA management, and ADPR activities to ensure regulatory compliance and customer satisfaction.

You will support quality systems, lean initiatives, and cross-functional projects across Manufacturing, Quality Control, and R&D teams. A 1–3+ year background in cGMP environments and a relevant bachelor's degree are preferred.