Deviation Specialist II

Thermo Fisher Scientific • Greenville, NC

6d • Onsite

About The Position

A leading pharmaceutical organization is 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 contributing to continuous improvement initiatives in a regulated environment. This role ensures that all deviations are managed in compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are implemented effectively. The ideal candidate will be a skilled technical writer with strong communication and problem-solving abilities, and a comfort level in navigating complex production environments.

Requirements

• 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.

Nice To Haves

• Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medial, or Quality Management with 2+ years of related experience.
• Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
• Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

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.

Benefits

• The company provides resources needed to achieve individual career goals.
• Opportunity to take science a step beyond by developing solutions for some of the world’s toughest challenges.
• Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed