Quality Systems and Compliance Specialist II

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

Quality Systems and Compliance Specialist II

$25-$31/hr

About ALK

ALK is a global pharmaceutical company specialising in allergy immunotherapy. For over 100 years, we have helped prevent, diagnose and treat allergies, improving lives through science, integrity and patient commitment.

Join ALK to support the quality and compliance of medicines that make a difference.

The role

You will maintain and improve the quality management system, ensuring compliance with regulations, procedures and quality standards. Working across the organisation, you will promote quality and continuous improvement.

Your responsibilities will include:

• 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.

Your profile

You have quality systems or compliance experience in a regulated environment, ideally in pharmaceuticals, biotechnology or life sciences.

You will also bring:

• Knowledge of quality management systems and relevant Good Manufacturing Practice (GMP).
• Experience with document control, deviations, CAPA, change control or audits.
• A relevant degree or equivalent scientific, technical or quality-related experience.
• Strong organisation and attention to detail.
• Clear communication and effective teamwork.
• A proactive, collaborative approach and interest in improvement.
• Good spoken and written English; additional languages are an advantage.

Become part of ALK

At ALK, high standards, openness and a shared commitment to improving lives guide our work. Join an international team where collaboration, learning and quality matter.

We value diversity, inclusion and wellbeing, and strive to create a supportive workplace where everyone can contribute.

All positions at ASM require the ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.

If you require further information please visit our website at www.alk.net/us