Quality Systems and Compliance Specialist II
Strengthen the quality systems behind life-changing allergy medicines, coordinating compliance, audits and improvements with teams across an international pharmaceutical company.
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.
Application
Submit your CV and application. We review applications on an ongoing basis, so apply as soon as possible using this link:
All positions at ASM require the ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.
To learn more about ALK, please visit our website at www.alk.net/us. If this position describes a fit for you, please submit through the link below.
No agencies or recruiters please, we cannot support sponsorship for this position at this time or in the future.
- Department
- Global Quality
- Location
- Post Falls
- Employment type
- Full-time
About ALK
Allergy impacts and challenges the lives of millions of adults and children every day. At ALK, our purpose is to improve the lives of people living with allergies. Building on our strong heritage, we are guided by our strategy, Allergy+, that shows us a clear path towards this goal through focus, innovation, cultivation and optimisation.
Read more about our corporate strategy and our ambitions for growth
Fair and unbiased recruitment at ALK
At ALK, we believe that every candidate deserves to be evaluated fairly and respectfully. Our recruitment process is designed to give each applicant an equal opportunity, regardless of their background. Read more about fair and unbiased recruitment at ALK.
If you are applying from North America, please know that we are committed to fair, unbiased and non-discriminatory recruitment practices and to complying with all applicable federal, state and local employment laws. Employment decisions are made based on qualifications, skills and experience, without discrimination on the basis of legally protected characteristics. For more information, please visit the official websites of the relevant authorities: U.S. Equal Employment Opportunity Commission (EEOC) and Office of Federal Contract Compliance Programs (OFCCP).
Your recruitment journey at ALK
Curious to learn more about our recruitment process? Please visit this page.