Thermo Fisher Scientific · 3 days ago
QA Specialist III, Quality on the Floor (12-hour nights)
Greenville, NC
Full-time
Onsite
Senior Level
5+ years expThermo Fisher Scientific Inc. is the world leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. The QA Specialist III will drive quality execution across sterile operations, providing quality guidance and expertise for process improvements and continuous initiatives.
Research
Responsibilities
Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs
Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
Champions quality culture by aiding personnel in understanding application of policies and controls
Participates in RAPID event response and provides quality guidance for deviation events
Advances deviation events to the appropriate area and quality management
Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
Performs quality review and approval of deviation and change control of moderate to high complexity
Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
Performs quality batch record review
Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives
Qualification
Required
Bachelor's degree, preferably in technology, engineering or microbiology related field required
5+ years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing required
Ability to capture data, analyze & troubleshoot process issues, equipment problems along with production leadership
Ability to troubleshoot process and equipment issues
Hard-working, demonstrated ownership & responsibility
Ability to lead, support & empower a team/peers
Technical Writing experience
Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning
Preferred
Previous experience in pharmaceutical industry, preferably with QA oversight experience within an aseptic or steriles filling and manufacturing operation strongly preferred
Experience in other GMP environments may be considered (i.e. ISO 9001)
An equivalent combination of education and relevant experience may be considered
Professional certifications (ex: CQA) and training (Six Sigma) are a plus
Benefits
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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