Lead Investigator

About the role

Responsible for ensuring root cause analysis is conducted on investigations for Aveva in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented. Acts as a quality technical resource and reviews all investigation reports for completeness, accuracy, and compliance. The Lead Investigator position requires the ability to handle a variety of tasks, meet timelines, and maintain cross‑functional interactions with Production, Technical Services, Engineering, Supply Chain, Quality Control and Quality Assurance.

Responsibilities

• Conduct all commercial deviations (product, validation, stability, process and procedures) and ensure investigations are initiated following existing procedures.
• Recognize critical path for investigations, leading to timely identification of root cause, corrective and preventative actions.
• Notify appropriate Team Leaders of validation, raw material, stability & in‑process failures and ensure investigations are initiated and completed as per existing procedure.
• Act as a quality technical resource and provide support & guidance to groups within Operations.
• Ensure identification of the most probable root cause, corrective action & preventative action for all completed investigations.
• Review all investigation reports for completeness and accuracy prior to approval by the Department Manager.
• Conduct impact analysis of proposed corrective & preventative actions.
• Discuss findings with impacted departments (OPS, TS, SC, ENG, QA, RA, etc.) and prepare recommendations for Department Managers.
• Prepare and maintain a list of open investigations for Aveva Management.
• Review ongoing progress on all open investigations with Aveva stakeholders.
• Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.
• Project manage the corrective and preventative actions and assist in both implementation and follow‑up.
• Ensure compliance with all Company policies and procedures, including safety rules and regulations.
• Operate in accordance with the Code of Conduct, Business Ethics, and all established regulatory, compliance and safety requirements.
• Perform all work in support of the company values: Collaboration, Courage, Perseverance, and Passion.
• Perform all other relevant duties as assigned.

Qualifications

Education: Associate or Bachelor’s degree in Sciences from an accredited college or university.

• Analyzing and troubleshooting problems, identifying solutions, and recommending and implementing methods, procedures, systems, and/or techniques for resolution.
• Experience in project management; fluency with project management and RCCA tools.
• Superior organizational and interpersonal communication skills.
• Ability to manage time effectively and work independently while managing multiple priorities in a fast‑paced, changing environment.
• Good command of the English language, both written and verbal.
• Knowledge of Current Good Manufacturing Practices (cGMPs), FDA, DEA, and other regulatory requirements.
• Proficiency with Microsoft Word, Excel, and SAP.
• 5–8 years of experience in a cGMP‑regulated manufacturing environment, or an equivalent combination of training and experience.