Quality Specialist II - Complaints

Work Schedule
First Shift (Days)
Environmental Conditions
Able to lift 40 lbs. without assistance, 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.)
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

Advanced degree with no prior experience, or Bachelor's 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
Proactive and capable of managing multiple tasks and meeting deadlines in a fast-paced environment with minimal supervision.
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