Thermo Fisher Scientific · 15 hours ago
Deviation Specialist II (12 hour days)
Greenville, NC
Full-time
Onsite
Mid LevelThermo Fisher Scientific is a leading pharmaceutical organization seeking a Deviation Specialist to support its quality and compliance operations within a high-volume sterile manufacturing facility. This role focuses on conducting thorough investigations, driving root cause analysis, and ensuring compliance with company policies and industry regulations regarding deviations.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines
Conduct thorough investigations to determine the root cause of deviations
Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs)
Maintain accurate and detailed records of all deviations, investigations, and CAPAs
Prepare and present deviation reports to management and regulatory authorities as required
Ensure documentation is completed in accordance with Good Documentation Practices (GDP)
Ensure all deviations are managed in compliance with company policies, industry standards, and regulatory requirements
Participate in internal and external audits and inspections, providing necessary documentation and information related to deviations
Analyze deviation trends and provide insights for continuous improvement initiatives
Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance
Qualification
Required
Regulated Industry, cGMP environment experience, deviation management, or a e.g., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc
Strong Attention to details, technical writing, Analytical and problem-solving skills
Knowledge of regulatory requirements and standards
Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
Excellent communication and interpersonal skills
Preferred
Associate or bachelor's degree in a relevant field such as Life Sciences, Engineering, Medical, or Quality Management
Preferred Experience: Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems
Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
Founded in 1956
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
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Marc Casper
CEO
Stephen Williamson
Senior Vice President and Chief Financial Officer
Recent News
Genetic Engineering News
2026-01-16
Investor's Business Daily
2026-01-16
Company data provided by crunchbase