Quality Control Compliance Specialist (f/m) (maternity cover) (Duchnice)
Duchnice, PL
Join Rezon Bio, where biotech experts create biologics that improve lives worldwide - not by following the old rules, but by finding better, more reasonable ways to do things.
Built on the excellence of Polpharma Biologics, Rezon Bio is evolving into a Contract Development and Manufacturing Organization (CDMO) with a clear reason: to challenge the status quo and raise the bar in biotech.
With state-of-the-art centers in Gdańsk and Warsaw-Duchnice, we offer career opportunities across science, technology, and business for those who want their work to truly resonate.
Work alongside 1,300 professionals who combine global ambitions with local roots – driven by science, purpose, innovation, and respect for diversity.
Our Quality Control department carries out activities related to process monitoring and cooperation with external partners to ensure the safety and efficacy of our products. The QC Compliance Specialist position does not involve direct laboratory work, but focuses on managing quality processes and supporting the team in compliance and documentation.
We are looking for a candidate to join the team and support quality objectives.
Your Responsibilities:
- Partcipation in sample management and activities related to product stability and archive.
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Assissting in processing deviations and Corrective and Preventive Actions (CAPA), control of changes and their effectiveness.
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Analyzing trends in product stability results and other quality Key Performance Indicators (KPIs).
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Cooperation with suppliers of reagents and services, including contract testing laboratories.
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Managing samples and Quality Control documentation.
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Participation in internal and external audits and inspection readiness preparations,
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Working with IT systems such as TrackWise (quality management system), SAP (Enterprise Resource Planning system), LIMS (Laboratory Information Management System), and EMS Flexdat.
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Supporting training processes and building quality culture within the department.
Our Expectations:
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Higher education, preferably in biotechnology, pharmacy, or related life sciences.
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At least 1 year of experience in the pharmaceutical or biotechnology industry.
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Very good command of English, both spoken and written.
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Knowledge of Good Manufacturing Practice (GMP) requirements.
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Proficiency in Microsoft Office, especially MS Excel.
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Strong communication skills and ability to collaborate with internal teams and external partners
We Offer:
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24 days of home office per year.
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Flexible working hours: single shift Monday to Friday, 7:00-15:00 or 8:00-16:00.
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Attractive benefits package: medical care, lunch card, subsidy for English language learning, subsidy for professional development (studies/courses/trainings), wide range of internal trainings, holiday allowance, massages.
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Subsidy for your holiday.
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Additional day off.
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Opportunities for professional development and internal promotion.
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Free employee shuttle bus.
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Stable employment in a fast-growing biotechnology company.
We fuel your professional growth and back it with a comprehensive benefits package. Our advanced facilities support both commercial-scale production and cutting-edge R&D, making us one of the most modern biotech organizations in Europe.
Here your ideas resonate and drive meaningful change. With continuous learning opportunities, many experts have already found their reason to return or relocate to Poland and grow their careers with us.
Does this resonate with you?
Learn more at RezonBio.com/careers and on LinkedIn