Quality Assurance Officer II

This is a fully remote position, open to applicants in Serbia.

📋 Description

• The Quality Assurance Officer II (Quality Officer II) is responsible for overseeing the development and management of Quality Management Systems documentation as necessary, conducting audits when appropriate, co-hosting and potentially leading customer audits, aiding in the resolution of quality issues/deviations/CAPA, participating in regulatory inspections, and carrying out quality control reviews of regulatory documents as required for the Allucent Quality Department and other quality tasks as assigned. This position is tasked with monitoring quality activities.

• **In this role, your key responsibilities will include:**

• - Overseeing the creation and management of quality documentation, such as SOPs, training materials, and sponsor documentation as directed.

• - Co-hosting and potentially leading customer audits.

• - Participating in regulatory inspections.

• - Conducting audits (e.g., process, project, vendor, investigator site), as appropriate.

• - Performing quality control reviews of regulatory documents as needed.

• - Potentially leading investigations into quality issues/deviations, managing follow-ups/closures, and CAPA closures as directed.

• - Providing essential oversight for training management, including the maintenance of training curricula and administration of the learning management system as directed.

• - Assisting in the creation and delivery of training materials in alignment with senior management directives.

• - Actively promoting staff learning and development within the organization.

• - Drafting and contributing, as a Subject Matter Expert (SME) in the field of Quality Officer, to the evaluation and unification of processes and procedures within the Quality Management System.

• - Ensuring effective communication and relationships with (future) clients.

• - Potentially participating in client evaluations, visits, and bid defenses.

• - May serve as the primary contact within the quality team for specific areas/assignments.

• - Supporting various other quality activities (e.g., RFI and vendor questionnaires, quality metrics, and CSV) as directed.

• - Contributing to other business areas and fulfilling additional duties as assigned.

⛳️ Requirements

• **To thrive in this position, you will need:**

• - A degree in life sciences, healthcare, or business.

• - A minimum of 3 years of relevant work experience.

• - At least 2 years of experience in drug development and/or clinical research.

• - Fundamental knowledge of ICH-GCP (R2), auditing, GDPR/HIPAA, CFR, and other pertinent (global/local) regulatory requirements.

• - A process-oriented mindset.

• - Strong analytical skills.

• - Excellent written and verbal communication skills, including a good command of the English language.

• - A representative, outgoing, and client-focused demeanor.

• - The ability to thrive in the fast-paced, challenging environment of a growing company.

• - Administrative excellence.

• - Proficiency in various computer applications such as Word, Excel, and PowerPoint.

• - Strong organizational abilities.

• - Effective time management skills.

🏝️ Benefits

• **Benefits of working at Allucent include:**

• - A comprehensive benefits package tailored to each location.

• - Competitive salaries based on location.

• - A departmental study/training budget to support professional development.

• - Flexible working hours (within reason).

• - Participation in our rewarding Buddy Program for new or existing employees.

• - Opportunities for internal growth and career advancement.

• - A financially rewarding internal employee referral program.

• - Eligibility for our Spot Bonus Award Program, which recognizes exceptional contributions to projects.

• - Eligibility for our Loyalty Award Program, which honors the loyalty and commitment of long-standing employees.