QA Deviation Specialist

Lonza•Tampa, FL

About The Position

The QA Deviation Specialist identifies, documents, investigates, and resolves deviations, unplanned events, and complaints 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 and facilitates investigations, works with departments across the organization to determine root causes and implement improvements, and assesses potential impacts on product quality and safety. The role also supports compliance initiatives, document updates, audits, and regulatory inspections, and may prepare and present reports to management and regulatory authorities.

Requirements

Bachelor’s degree in science; chemistry is preferred.
3 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.

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 partner 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 the potential impact of deviations on product quality and product safety, identity, strength, quality, or purity.
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 addressing compliance gaps identified during investigations, with minimal assistance.
Use professional judgment to escalate issues appropriately to management.
Prepare and present deviation reports to management and regulatory authorities as needed.
Ensure documentation follows Good Documentation Practices.
Support regulatory inspections, internal audits, and customer audits as required.
Perform additional job-related assignments as requested by management.