Quality On The Floor Associate

7 giorni fa

Bresso, Italia AGC Biologics A tempo pieno

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Key Responsibilities:

- Perform on-the-floor oversight of manufacturing operations to ensure compliance with cGMP and SOPs
- Support production teams by providing real-time guidance on quality-related matters
- Escalate and support the investigation of deviations, non-conformances, and other quality events
- Participate in root cause analysis and CAPA implementation
- Collaborate with cross-functional teams (Production, Engineering, QC) to ensure quality standards are upheld
- Support training and coaching of operators on GMP and quality best practices
- Ensure data integrity and good documentation practices in all activities
- Support internal and external audits, inspections, and readiness activities
- Ensure accurate and timely alarm management

Requirements:

- Bachelor's degree in a scientific discipline (Pharmacy, Chemistry, Biology, or related field)
- Minimum 1 year of experience in a pharmaceutical manufacturing environment, in a QA or production-related role
- Solid understanding of GMP regulations and quality assurance principles
- Strong attention to detail and problem-solving skills
- Effective communication skills and ability to work cross-functionally
- Experience with sterile/aseptic manufacturing

Preferred Qualifications:

- Knowledge of deviation management systems (TrackWise)
- Knowledge of alarm management systems (SCADA)
- Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe._
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- AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances._

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