Quality Assurance Coordinator

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Job Description Summary

The Quality Assurance Coordinator will provide operational and administrative support to the Global Quality Assurance function, helping ensure the effective maintenance, tracking, and administration of Quality Management System activities.
Key responsibilities will include supporting the tracking and follow-up of quality events such as deviations, CAPAs, and complaints; assisting with the migration of existing quality records into the Qualio electronic Quality Management System (eQMS); supporting the administration and maintenance of quality records and trackers; and triaging requests received through the QA inbox, including training requests, Qualio enquiries, and other routine Quality Assurance support needs.
The role will work closely with members of the Global Quality Assurance team to ensure requests and quality activities are appropriately documented, routed, followed up, and completed in accordance with established procedures and timelines.
The ideal candidate will have previous experience in Quality Assurance, Quality Systems, or a related role within the pharmaceutical, biotechnology, medical device, CRO, or other regulated life sciences environment. Familiarity with electronic Quality Management Systems, document control, training administration, deviations, CAPAs, and other quality processes is preferred. Strong organizational skills, attention to detail, follow-up capabilities, and proficiency in English are essential.

Job Description

ESSENTIAL JOB FUNCTIONS

The Quality Assurance Coordinator will support the Global Quality Assurance team with day-to-day Quality Management System administration and coordination activities.

Key responsibilities include:

• Maintain and update QA trackers and support follow-up of quality events, including deviations, CAPAs, complaints, and associated actions and due dates.
• Follow up with relevant stakeholders on outstanding actions, documentation, approvals, and quality-related requests.
• Support migration of manual and legacy quality records into the Qualio eQMS, ensuring records are complete, accurate, and appropriately organized.
• Support ongoing administration and maintenance of records within Qualio.
• Triage requests received through the QA inbox and route requests to the appropriate QA team member when escalation or quality judgment is required.
• Support routine training administration, including processing training requests, maintaining training-related records, and following up on outstanding activities.
• Respond to or appropriately route routine Qualio user enquiries and administrative requests.
• Support document and record management activities, including filing, naming, organization, and maintenance of controlled quality records.
• Assist with preparation of quality metrics, status reports, and routine QA follow-up activities, as required.

Support other administrative and operational Quality Assurance activities assigned by the Global Quality Assurance team

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

· Approximately 1–2 years of experience in Quality Assurance, Quality Systems, document control, or a related role, preferably within the pharmaceutical, biotechnology, medical device, CRO, or other regulated life sciences environment.

· Basic understanding of Quality Management System concepts and quality processes such as deviations, CAPAs, complaints, training, and controlled documentation.

· Previous experience with an electronic Quality Management System is an advantage.

· Strong organizational skills with the ability to track multiple activities, deadlines, and follow-up actions.

· High attention to detail and commitment to accurate recordkeeping.

· Strong written and verbal communication skills.

· Ability to work independently on established processes while appropriately escalating questions requiring QA review or decision-making.

· Proficiency in English.

Languages

Education

Contract Type

Contingency Workforce

Salary Range

The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.

About Us

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

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