Role at a glance
- Salary
- Not Disclosed
- Location
- Ferentino, Italy
- Work arrangement
- Hybrid
- Employment
- Full-time
- Experience
- Bachelor's Degree required, no prior experience required, preferably in a GMP manufacturing environment • Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field • Additional relevant certifications (e.g. ISO auditor, Six Sigma) are advantageous • Thorough knowledge of FDA, EMA, and international GMP regulations • Proven ability to review and approve GMP documentation, batch records, and quality records • Strong understanding of quality management systems and tools (e.g. CAPA, change control) • Excellent documentation and technical writing skills • Proficiency with quality systems software and Microsoft Office applications • Strong analytical and problem-solving abilities with keen attention to detail • Outstanding verbal and written communication skills • Ability to work independently and collaborate effectively across functions • Experience conducting quality investigations and root cause analysis
- Education
- Bachelor's Degree required, no prior experience required, preferably in a GMP manufacturing environment
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Role Summary
This Quality Specialist I role provides quality oversight in manufacturing operations through detailed documentation review, process monitoring, and collaboration with cross-functional teams. The role helps maintain GMP compliance, investigates quality events, and drives continuous improvement initiatives.
What You'll Do
- Provide quality oversight through detailed documentation review and process monitoring
- Collaborate with cross-functional teams on quality oversight
- Help maintain GMP compliance
- Investigate quality events
- Drive continuous improvement initiatives
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Bachelor's degree required, with GMP, quality systems, documentation, and communication skills listed as requirements; scientific degree fields and certifications are preferred.
Required
- Bachelor's Degree
- Thorough knowledge of FDA, EMA, and international GMP regulations
- Proven ability to review and approve GMP documentation, batch records, and quality records
- Strong understanding of quality management systems and tools (e.g. CAPA, change control)
- Excellent documentation and technical writing skills
- Proficiency with quality systems software and Microsoft Office applications
- Strong analytical and problem-solving abilities with keen attention to detail
- Outstanding verbal and written communication skills
Preferred
- Degree preferably in a GMP manufacturing environment
- Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field
- Additional relevant certifications (e.g. ISO auditor, Six Sigma)
- Additional language skills
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.DESCRIPTION:
Join our high-performing team at Thermo Fisher Scientific, where you'll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier, cleaner, and safer. As a Quality Specialist I, you'll provide essential quality oversight through detailed documentation review, process monitoring, and collaboration with cross-functional teams. You'll help maintain GMP compliance, investigate quality events, and drive continuous improvement initiatives while working in a collaborative environment focused on delivering life-changing products to our customers.
REQUIREMENTS:
• Bachelor's Degree required, no prior experience required, preferably in a GMP manufacturing environment
• Preferred Fields of Study: Chemistry, Biology, Engineering, Life Sciences, or related scientific field
• Additional relevant certifications (e.g. ISO auditor, Six Sigma) are advantageous
• Thorough knowledge of FDA, EMA, and international GMP regulations
• Proven ability to review and approve GMP documentation, batch records, and quality records
• Strong understanding of quality management systems and tools (e.g. CAPA, change control)
• Excellent documentation and technical writing skills
• Proficiency with quality systems software and Microsoft Office applications
• Strong analytical and problem-solving abilities with keen attention to detail
• Outstanding verbal and written communication skills
• Ability to work independently and collaborate effectively across functions
• Experience conducting quality investigations and root cause analysis
• Knowledge of environmental monitoring and contamination control principles
• Flexibility to work various shifts as needed to support manufacturing operations
• Ability to gown and work in controlled manufacturing environments when required
• Physical capability to stand, walk, and lift up to 25 pounds occasionally
• Sound judgment and decision-making skills
• Commitment to maintaining a quality-focused culture and driving continuous improvement
• Fluency in English required; additional language skills beneficial
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.