Quality Specialist II - Complaints

Thermo Fisher Scientific • Greenville, NC

2d

About The Position

As part of Thermo Fisher Scientific, the Quality Specialist II contributes to global healthcare and scientific advancement by ensuring compliance with GMP standards, FDA regulations, and international quality requirements. The role supports manufacturing operations across multiple product lines and works with cross-functional teams to implement continuous improvement initiatives, conduct investigations, and maintain quality management systems. The work supports the company's mission to make the world healthier, cleaner, and safer.

Requirements

• Advanced degree with no prior experience, or a bachelor's degree with 2 years of experience in pharmaceutical or biotech manufacturing, quality assurance, or a related GMP environment.
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements.
• Experience with quality management systems and documentation, such as TrackWise, Master Control, or equivalent.
• Experience in deviation investigations, CAPA, change control, and root cause analysis.
• Proficiency in Microsoft Office 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 approach and ability to manage multiple tasks, meet deadlines in a fast-paced environment, and work 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.
• Ability to work various shifts to support manufacturing operations.
• Ability to travel up to 10%.
• Ability to stand and walk for extended periods and occasionally lift up to 25 lbs.

Nice To Haves

• Preferred fields of study include Biology, Chemistry, Engineering, Life Sciences, or a related scientific field.
• Additional language skills may be beneficial.

Responsibilities

• Ensure compliance with GMP standards, FDA regulations, and international quality requirements.
• Support manufacturing operations across multiple product lines.
• Work with cross-functional teams to implement continuous improvement initiatives.
• Conduct investigations, including deviation investigations and root cause analysis.
• Maintain quality management systems and related documentation.
• Support internal audits and external regulatory inspections.
• Work in cleanroom environments and follow gowning procedures where required.
• Support manufacturing operations across various shifts as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level