Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

Location: This role is located onsite (M-F) in Greenville, NC.

Job Summary:

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.

Key Responsibilities:

Deviation Management:

• 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).

Documentation and Reporting:

• 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).

Compliance and Quality Assurance:

• 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.

Continuous Improvement:

• Analyze deviation trends and provide insights into continuous improvement initiatives.
• Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.

Qualifications:

• Experience in cGMP environment, deviation management, or equivalent regulated industry.
• Strong Attention to details, technical writing, Analytical and critical thinking skills.
• Knowledge of regulatory requirements and standards.
• Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
• Excellent communication and people skills.

Preferred Qualifications:

• Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medical, or Quality Management.
• Preferred Experience: 1-3 years of Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
• Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Physical Demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as- dust, fumes or odors, temperature extremes, loud noise, strong drafts or bright lights.

Work Environment:

This job operates in a professional office environment as well as the Production, Laboratory and Warehouse environment in a pharmaceutical facility. This role routinely involves use of standard office equipment such as computers, phone, photocopiers, filing cabinets and fax machines.