Quality Specialist II - Clinical Label Services

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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.

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.

Key Responsibilities:

• Review batch records for completeness, accuracy, and compliance with GMP requirements
• Manage archiving of quality documentation in accordance with regulatory standards
• Support incoming and outgoing inspections of labels and packaging materials
• Act as point of contact to initiate pre-investigations for deviations and ensure timely escalation
• Collaborate with cross-functional teams to collect data and support deviation investigations
• Assist in writing investigation reports, including root cause analysis and corrective/preventive actions (CAPAs)
• Support change control activities, including documentation, review, and tracking through implementation
• Ensure all QA activities comply with internal quality systems and regulatory requirements

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 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
• 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 German and English, additional language skills beneficial