Quality Assurance & Regulatory Affairs Sr Analyst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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 Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.

REQUIREMENTS:
• Bachelor's degree with +2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment.
• Fields of Study: Pharmacist with degree.
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Knowledge with quality management systems and documentation (TrackWise, Master Control, or equivalent)
• Experience in deviation investigations, CAPA, change control, and root cause analysis

• Experience with GxP equipment validation & qualification.
• Proficient in Microsoft Office suite
• Technical writing and documentation skills
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Some experience conducting internal audits and receiving external regulatory inspections
• Project management and organizational skills
• Intermediate oral english and advance written english
• Up to 10% travel may be required