Quality Assurance Officer

Allucent

Multiple Locations

We are looking for a Quality Assurance (QA) Officer to join our A-team (hybrid*/remote). As a QA Officer at Allucent, you are responsible for coordinating development and management of Quality Management Systems documents as needed, perform audits as appropriate, co-hosts and may lead customer audits, supports quality issue/deviation/CAPA closures, participates in regulatory inspections, and performs quality control review of regulatory documents as needed of Allucent Quality Department and other quality activities as directed. This position monitors quality activities.

In this role your key tasks will include:

Development and management of quality documentation, including but not limited to, SOPs, training, and sponsor documentation as directed
Co-host and may lead customer audits
Participate in regulatory inspections
Perform audits (e.g., process, project, vendor, investigator site), as appropriate
Perform quality control review of regulatory documents as needed
May lead quality issue/deviation investigation, follow-up/closure, and CAPA closures as directed
Provide essential training oversight management, leading maintenance of training curricula and learning management system administration as directed
Assist with the development and delivery of training materials as agreed with senior management
Actively support staff learning & development within the company
Draft and contribute, as Subject Matter Expert (SME) in the field of Quality Officer, activities to the evaluation and harmonization of processes and procedures within the Quality Management System
Assure good communication and relationships with (future) clients
May contribute and take part in client evaluations, visits and bid defenses
May act as primary contact within the quality staff for dedicated areas/assignments
Support other quality activities (e.g., RFI and vendor questionnaire, quality metrics and CSV) as directed
Contribute to other areas of business and other duties as assigned

Requirements:

To be successful you will possess:

Life science, healthcare and/or business degree
Minimum 3 years of relevant work experience
Minimum 2 years of experience in drug development and/or clinical research
Basic knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR and other applicable (global/local) regulatory requirements
Process oriented
Analytical skills
Written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Strong organizational skills
Time management skills