Quality Specialist III (1 Day Shift & 2 Night Shift Positions)

Thermo Fisher Scientific • Greenville, NC

1d • Onsite

About The Position

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. As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group, comprising approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization. There are 3 positions available: one day shift/12-hour (6am-6pm) and two 12-hour night shifts (6pm-6am) on a 3-2-2 rotation, with flexibility to work overtime as needed. Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner and safer.

Requirements

• At least an Associate's degree required
• 5+ years of experience with Associates, or 3-5 years of experience with a BS degree in quality assurance/quality control within regulated industries required (pharmaceutical, medical device, biotech preferred)
• Experience with quality management systems, CAPA processes, deviation management, and change control
• Experience conducting and hosting internal/external audits and regulatory inspections
• Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements
• Demonstrated expertise in root cause analysis, investigation techniques, and corrective action implementation
• Proficiency in statistical analysis, data trending, and quality metrics reporting
• Strong technical writing skills for authoring SOPs, investigation reports, and other quality documentation
• Advanced problem-solving abilities and attention to detail
• Excellent verbal and written communication skills
• Strong interpersonal skills with ability to collaborate across functions and levels
• Proficiency with quality systems software (TrackWise, Document Control Systems) and Microsoft Office Suite
• Ability to work independently and guide cross-functional teams

Nice To Haves

• BS Degree highly preferred
• Preferred Fields of Study: Life Sciences, Engineering, Chemistry, Biology or related technical field
• Project management experience preferred
• Knowledge of risk assessment methodologies and continuous improvement tools

Responsibilities

• Collaborate with cross-functional teams to investigate quality issues
• Conduct audits
• Manage documentation
• Implement corrective actions
• Foster a culture of quality excellence throughout the organization
• Maintain regulatory compliance
• Drive continuous improvement of quality systems

Benefits

• Competitive remuneration
• Annual incentive plan bonus scheme
• Healthcare
• A range of employee benefits
• Outstanding career and development prospects

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees