Deviation Specialist II

Work Schedule

Environmental Conditions

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 for continuous improvement initiatives.
• Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.

Qualifications:

• 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 Qualifications:

• HS degree required, Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medical, or Quality Management preferred.
• Preferred Experience: Biologics, Aseptic, Filling Isolators, Six Sigma Certification, 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.