Quality Specialist III

Work Schedule First Shift (Days) Environmental Conditions Office 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. Excellent Benefits Package Review our company's Total Rewards Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Holidays 401K Company Match up to 5% Tuition Reimbursement - eligible after 90 days! Employee Referral Bonus Employee Discount Program Recognition Program Charitable Gift Matching Company Paid Parental Leave Career Advancement Opportunities Group/Division Summary The Drug Product Division - North America (DPD-NA), part of the Pharma Services Group, consists of approximately 4,400 colleagues across six sites. The division specializes in taking sterile injectable and oral solid dose drug products from development through commercialization.

Discover Impactful Work:

In this role, you will drive quality execution across sterile operations, including manufacturing, filling, packaging, and inspection. You will support both commercial and product development services while ensuring compliance with cGMP standards. This position also plays a key role in implementing process improvements and fostering a culture of continuous quality enhancement. A Day in the

Life:

Perform daily quality assessments of facilities, personnel, and documentation in classified and non-classified areas Interact with employees to troubleshoot issues and reinforce aseptic techniques Champion a strong quality culture Review and approve procedures, training documents, and forms Conduct quality batch record reviews Participate in continuous improvement initiatives Support client interactions and regulatory inspections Develop and maintain SOPs and training materials Partner with operations to improve documentation accuracy Keys to

Success:

Education:

Bachelor's degree required (scientific field preferred)

Experience:

Minimum of 5 years of experience in QA, QC, or Manufacturing Pharmaceutical industry experience preferred (aseptic/sterile strongly preferred) Experience in regulated environments (e.g., ISO) acceptable

Knowledge, Skills, Abilities:

Strong understanding of cGMP Troubleshooting and problem-solving ability Strong documentation and review skills Ability to lead and support teams Strong communication and collaboration Competencies Ownership and accountability Quality-focused mindset Continuous improvement Effective communication Team collaboration

Physical Requirements:

Ability to stand, walk, stoop, kneel, and crouch for extended periods Lift and move 10-35 pounds Manual dexterity and visual acuity Ability to sit, reach, talk, and hear for extended periods Use of PPE including safety glasses, lab coat, gloves, and respirator as needed