Quality Assurance Officer II
New
A
AllucentClinical Research, Life Science
Belgrade, Vojvodina, Serbia. Warsaw, Masovian Voivodeship, Poland. Sofia, Sofia City Province, Bulgaria. Prague, Prague, Czechia. Budapest, Budapest, HungaryFull-TimeMiddle
SalaryCompetitive salaries per location
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Job Details
- Languages
- English
- Experience
- Minimum 3 years of relevant work experience; Minimum 2 years of experience in drug development and/or clinical research
- Required Skills
- Microsoft ExcelPowerPointHIPAA
Requirements
- Degree in life science, healthcare, or business.
- Minimum 3 years of relevant work experience.
- Minimum 2 years of experience in drug development and/or clinical research.
- Knowledge of ICH-GCP (R2) and regulatory requirements such as GDPR, HIPAA, and CFR.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Strong organizational and time management skills.
- Excellent written and verbal communication skills in English.
- Strong analytical and process-oriented mindset.
- Ability to work in a fast-paced environment.
Responsibilities
- Develop and manage quality documentation, including SOPs and training materials.
- Co-host and lead customer audits.
- Participate in regulatory inspections.
- Perform process, project, vendor, and investigator site audits.
- Conduct quality control reviews of regulatory documents.
- Lead quality issue, deviation investigation, and CAPA closures.
- Manage training curricula and learning management system administration.
- Support quality metrics, RFI, and vendor questionnaires.
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