Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific this role youll ensure compliance with GMP standards FDA regulations and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams youll implement continuous improvement initiatives conduct investigations and maintain quality management systems that enable our mission of making the world healthier cleaner and safer.
REQUIREMENTS:
Advanced degree with no prior experience or Bachelors degree with 2 years of experience in pharmaceutical/biotech manufacturing quality assurance or related GMP environment
Preferred Fields of Study: Biology Chemistry Engineering Life Sciences or related scientific field
Knowledge of cGMP regulations ISO standards (9001/13485) and international regulatory requirements
Experience with quality management systems and documentation (TrackWise Master Control or equivalent)
Experience in deviation investigations CAPA change control and root cause analysis
Proficient in Microsoft Office suite and quality management software systems
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
Experience conducting internal audits and supporting external regulatory inspections
Project management and organizational skills
Ability to work in cleanroom environments and follow gowning procedures where required
Additional language skills may be beneficial
Up to 10% travel may be required
Must be able to work various shifts to support manufacturing operations
Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs
Required Experience:
IC
Employment Type : Full-Time
Experience: years
Vacancy: 1