GMP Quality & Compliance Specialist II – Audit & Training

ALK; Post Falls (ID); On-site; USD 34,000 - 43,000; Full time

Job summary

ALK is a global pharmaceutical company specializing in allergy immunotherapy. The Quality Systems and Compliance Specialist II will maintain and improve the quality management system to ensure regulatory compliance and drive continuous improvement across the organization.

The role involves leading GMP audits, training initiatives, and document control to support inspections and regulatory readiness. Successful candidates will have GMP and quality systems experience in a regulated environment,

Qualifications

• Experience with quality management systems and GMP.

Responsibilities

• Own and administer the site's internal GMP audit program.
• Support Quality Systems, including Document Control, Training, Change Control, and Compliance.
• Lead and support training program initiatives, including system implementation and employee qualification activities.
• Deliver GMP and quality systems training to employees.
• Manage electronic document management and controlled document issuance processes.
• Support inspection readiness and regulatory inspection activities.
• Partner with site departments to ensure compliance with GMP and company requirements.
• Drive continuous improvement of quality systems and compliance programs.
• Provide subject matter expertise on quality and regulatory requirements.

Skills

Quality management

GMP compliance

Document control

CAPA

Change control

Audits

Training delivery

Regulatory readiness

Team collaboration

Education

Relevant science degree

Tools

Document management software

Job description

ALK is a global pharmaceutical company specializing in allergy immunotherapy. The Quality Systems and Compliance Specialist II will maintain and improve the quality management system to ensure regulatory compliance and drive continuous improvement across the organization.

The role involves leading GMP audits, training initiatives, and document control to support inspections and regulatory readiness. Successful candidates will have GMP and quality systems experience in a regulated environment,