Quality Specialist I

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 youll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier cleaner and safer. As a Quality Specialist I youll provide essential quality oversight through detailed documentation review process monitoring and collaboration with cross-functional teams. Youll 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:
Bachelors Degree required 2 years experience required preferably in a regulated 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
Knowledge of ISO specific regulations
Proven ability to review and approve GMP type 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
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