Work Schedule

Environmental Conditions

Job Description

Job Title: Deviation Specialist (On Site)

Location: Greenville, North Carolina

Department: Manufacturing Technology

Reports To: ……..

Job Summary: The Deviation Specialist is responsible for identifying, documenting, investigating, and resolving deviations from standard procedures, protocols, or regulatory requirements. 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.

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 the need arises.Ensure that documentation is completed following 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 for continuous improvement initiatives.Participate in training programs to improve knowledge and skills related to deviation management and quality assurance.

Qualifications:

Preferred: Bachelor’s degree in a relevant field such as Life Sciences, Engineering, or Quality Management.2 years of experience in quality assurance, deviation management, or a related role in [industry, e.g., pharmaceuticals, manufacturing, etc.].Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards.Strong analytical and problem-solving skills.Excellent communication and interpersonal skills.Proficiency in quality management systems (QMS) and relevant software tools.

Preferred Qualifications:

Certification in Quality Management (e.g., Six Sigma, ASQ).Experience with electronic documentation systems.Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Working Conditions:

This job operates in a professional office environment as well as the Production, Laboratory, and Warehouse environment in a pharmaceutical facility.While performing the duties of this role, the employee is required to walk, sit, and use hands to handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk, and hear. The work is typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as temperature extremes, loud noise, strong drafts, or bright lights.