Lead Investigator

Aveva Drug Delivery Systems Inc; Florida; On-site; USD 85,000 - 110,000; Full time

Job summary

Aveva Drug Delivery Systems Inc in Florida is seeking a Lead Investigator to drive root-cause analyses and ensure timely investigations with effective corrective and preventive actions. You will coordinate across Production, Technical Services, Engineering, Supply Chain, Quality Control and Quality Assurance to close investigations per procedures.

The role requires an associate or bachelor’s degree in sciences, strong analytical and project-management skills, and knowledge of cGMP, FDA

Qualifications

• Analytical problem solving and troubleshooting.
• Experience in project management and coordination across functions.
• Familiarity with cGMP, FDA, and regulatory requirements.

Responsibilities

• Conducts investigations (product, process, deviations) and initiates corrective actions.
• Identify root causes and develop corrective and preventive actions.
• Lead cross-functional reviews with OPS, TS, SC, ENG, QA, RA.
• Prepare open investigations list and monitor progress with stakeholders.
• Project manage CAPA implementation and follow-up.
• Ensure compliance with company policies, safety rules and ethics.

Skills

Root cause analysis

Project management

cGMP knowledge

FDA compliance

SAP

Word & Excel

Education

Associate or Bachelor's degree in Sciences

Tools

RCCA tools

Job description

Job Summary: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 quality technical resource and reviews all investigation reports for completeness and acccuracy, 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.Job Responsibilities• Conducts all commercial deviations (product, validation, stability, process and procedures) and ensures investigations are initiated following existing procedure.• Recognize critical path for investigations leading to timely identification of root cause, corrective & 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 quality technical resource and provide support & guidance to groups within Operations.• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Review all investigation reports for completeness and accuracy prior to approval by 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 list of open investigation for Aveva Management.• Review on-going 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 manages the corrective and preventative actions and assists in both implementation and follow-up.• Ensures compliance with all Company policies and procedures including safety rules and regulations.• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion• All other relevant duties as assigned.Job Requirements• EducationAn Associate or Bachelor’s degree in Sciences from an accredited college or university.• Knowledge, Skills and Abilities• Analyzing and troubleshooting problems, identifying solutions and recommending and implementing methods, procedures, systems and/or techniques for resolution.• Experience in project management• Fluency in project management & RCCA tools• Superior organizational, interpersonal communication skills• Ability to manage time effectively• Ability to work independently and manage multiple priorities in a fast-paced and changing environment• Good command of the English language, both written and verbal• Knowledge of Current Good Manufacturing Practices,(cGMPs), Food and Drug Administration (FDA), Drug Enforcement Administration(DEA), and other regulatory requirements.• Proficiency with Word, Excel, and SAP.• Experienceo 5-8 years experience experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.