Deskripsi Pekerjaan
Join Lonza as an Analyst, QC - Environmental Monitoring (EM) and play a pivotal role in safeguarding product quality through rigorous environmental surveillance. In this critical position, you will conduct comprehensive monitoring of cleanrooms and manufacturing areas to ensure compliance with stringent regulatory standards. Your expertise will be instrumental in detecting microbial and particulate contamination, implementing corrective actions, and maintaining aseptic conditions that protect product integrity. Working with state-of-the-art laboratory equipment and following Good Manufacturing Practices (GMP), you'll generate accurate documentation and collaborate with cross-functional teams to uphold Lonza's reputation for excellence in pharmaceutical manufacturing. This role offers an opportunity to develop advanced skills in quality assurance while contributing to life-saving therapies in a dynamic, science-driven environment.
Tanggung Jawab
- Execute routine environmental monitoring (air, surface, personnel) in cleanrooms and controlled manufacturing areas
- Analyze samples for microbial and particulate contamination using laboratory techniques
- Document monitoring activities and investigate deviations/out-of-specification results
- Calibrate and maintain monitoring equipment to ensure operational accuracy
- Implement corrective actions based on monitoring data and risk assessments
- Adhere strictly to GMP regulations, SOPs, and company quality policies
- Collaborate with production and quality teams to maintain contamination control
- Prepare detailed reports and maintain electronic batch records
Kualifikasi
- Bachelor's degree in Microbiology, Biology, Chemistry, or related Life Sciences field
- Minimum 1-2 years of experience in environmental monitoring within pharmaceuticals/biotech
- Familiarity with GMP regulations and cleanroom monitoring protocols
- Proficiency in laboratory techniques (microbial testing, aseptic handling)
- Strong attention to detail and data analysis capabilities
- Ability to work independently and follow complex procedures
- Excellent documentation and communication skills
- Basic knowledge of ISO 14644 standards for cleanroom classification