QA Deviation Specialist

Lonza•Tampa, FL

About The Position

The QA Deviation Specialist identifies, documents, investigates, and resolves deviations, unplanned events, and complaint investigations in accordance with company SOPs, policies, cGMPs, protocols, and regulatory requirements. This cross-functional role interacts with all departments at Lonza Tampa and authors, reviews, and/or provides final Quality approval for investigations into manufacturing, packaging, and laboratory events or deviations. The specialist leads assigned investigations across multiple areas, collaborates with relevant departments to determine root causes and implement improvements, analyzes deviation trends, and ensures timely completion and closure of investigations. The role assesses potential impacts on product quality and safety, defines corrective and preventive actions and criteria for evaluating their effectiveness, reviews and approves company documents, and helps address compliance gaps. The position also prepares and presents reports, supports audits and inspections, and ensures documentation follows Good Documentation Practices.

Requirements

Bachelor’s degree in science; chemistry is preferred.
Three years of experience in quality assurance, deviation management, or a related role.
Knowledge of regulatory requirements, such as FDA, EMA, and ISO, and industry standards.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.

Nice To Haves

Chemistry degree.

Responsibilities

Facilitate and lead assigned investigations involving multiple investigation areas.
Work with manufacturing, packaging, quality control, maintenance, engineering, supply chain, and other departments to conduct investigations, determine root cause, and implement improvements.
Use structured root cause analysis tools, such as fishbone diagrams and the 5 Whys, and collaborate with team members to identify the true root cause.
Analyze deviation trends and provide insights for continuous improvement initiatives.
Ensure investigations and reports are completed and closed within specified timelines.
Assess deviation potential impact on product quality, safety, identity, strength, quality, or purity, including root cause and corrective or preventive actions.
Determine actions to prevent recurrence and define criteria for evaluating CAPA effectiveness.
Review, update, and approve Standard Operating Procedures and other company documents.
Facilitate and participate in initiatives to address compliance gaps identified during investigations.
Use professional judgment to escalate issues appropriately to management.
Prepare and present deviation reports to management and regulatory authorities as needed.
Ensure documentation is completed in accordance with Good Documentation Practices.
Support regulatory inspections, internal audits, and customer audits as required.
Perform additional job-related assignments as requested by management.