Quality Assurance & Regulatory Affairs Sr Analyst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

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.

DESCRIPTION:
Join our Quality Assurance & Regulatory Affairs team at Thermo Fisher Scientific, where you'll contribute to ensuring product quality and regulatory compliance. As a QA Supervisor, you'll lead and develop a team of quality professionals while overseeing quality operations including batch record review, quality monitoring, and continuous improvement initiatives. You'll collaborate with cross-functional teams to enhance quality excellence and maintain our high standards for product safety and compliance. This position offers the opportunity to contribute by helping ensure the quality of products that enable our customers to make the world healthier, cleaner and safer.

REQUIREMENTS:

• Pharmacist with 1-2 years of experience in quality assurance and regulatory affaris in a regulated manufacturing or distribution environment (mandatory being pharmacist)
• Experience within pharma, healthcare or biotech industries
• Fluent in english
• Good knowledge and /or experience with cGMP regulations, local regulations and quality systems
• Experience with quality management software systems (e.g., TrackWise, SAP)
• Experience with deviation management and CAPA systems
• Experience with documentation systems and electronic quality management tools
• Experience hosting regulatory inspections and customer audits
• Understanding of validation and qualification principles and requirements
• Ability to support quality culture and continuous improvements
• Excellent project management and organizational skills
• Ability to build relationships and collaborate across all organizational levels
• Ability to effectively manage multiple responsibilities in a deadline-oriented environment