Quality Control Compliance Specialist - Remote Opportunity

About the Role

We are seeking a Quality Control Compliance Specialist to join our team at Rezon Bio. This remote opportunity allows you to contribute to our mission of ensuring product safety and efficacy without direct laboratory work. As a Quality Control Compliance Specialist, you will manage quality processes and support compliance and documentation efforts.

What You'll Do

• Participate in sample management and activities related to product stability and archiving.
• Assist in processing deviations and Corrective and Preventive Actions (CAPA), ensuring control of changes and their effectiveness.
• Analyze trends in product stability results and other quality Key Performance Indicators (KPIs).
• Cooperate with suppliers of reagents and services, including contract testing laboratories.
• Manage samples and Quality Control documentation efficiently.
• Participate in internal and external audits and prepare for inspections.
• Work with IT systems such as TrackWise, SAP, LIMS, and EMS Flexdat.
• Support training processes and foster a quality culture within the department.

Requirements

• Higher education in biotechnology, pharmacy, or related life sciences.
• At least 1 year of experience in the pharmaceutical or biotechnology industry.
• Very good command of English, both spoken and written.
• Knowledge of Good Manufacturing Practice (GMP) requirements.
• Proficiency in Microsoft Office, especially MS Excel.
• Strong communication skills and ability to collaborate with internal teams and external partners.

Nice to Have

• Experience with quality management systems.
• Familiarity with regulatory compliance standards.
• Previous experience in audit preparation.

What We Offer

• 24 days of home office per year.
• Flexible working hours: single shift Monday to Friday, 7:00-15:00 or 8:00-16:00.
• Attractive benefits package including medical care, lunch card, and subsidies for English language learning and professional development.
• Wide range of internal trainings and holiday allowance.
• Additional day off and opportunities for professional development and internal promotion.
• Free employee shuttle bus.
• Stable employment in a fast-growing biotechnology company.