QA Deviation Specialist

Lonza; Tampa (FL); On-site; Confidential; Full time

Job summary

Lonza Tampa is seeking a QA Deviation Specialist to lead investigations into deviations and unplanned events, ensuring compliance with cGMPs and regulatory requirements.

You will collaborate with manufacturing, quality control, maintenance, and supply chain to determine root causes, implement CAPAs, and prepare deviation reports for management and regulatory bodies. A Bachelor's degree in science and 3 years QA experience are required.

Qualifications

• Bachelor's degree in science; 3+ years in quality assurance or deviation management; knowledge of regulatory requirements (FDA/EMA/ISO).
• Strong analytical and problem-solving skills, with excellent communication and interpersonal abilities.
• Experience leading investigations, root-cause analysis, and CAPA effectiveness assessments.

Responsibilities

• Lead investigations into deviations and unplanned events across multiple areas.
• Collaborate with manufacturing, quality control, maintenance, engineering, and supply chain to determine root causes and implement improvements.
• Perform structured root cause analysis (fishbone, 5 Why) and assess impact on product quality and safety.
• Prepare and present deviation reports to management and regulatory authorities.
• Ensure documentation adheres to Good Documentation Practices (GDP) and supports regulatory inspections.

Skills

Quality assurance

Root cause analysis

Cross-functional collaboration

Regulatory knowledge

Analytical thinking

Education

Bachelor's degree in science

Job description

The QA Deviation Specialist is responsible for identifying, documenting, investigating, and resolving deviations, unplanned events, complaint investigations in accordance with company SOPs, policies, cGMPs, protocols, or regulatory requirements. This is a cross-functional position that interacts with all departments at Lonza Tampa. The role is responsible for authoring, reviewing, and/or providing the final Quality approval for investigations into manufacturing, packaging and/or laboratory events/deviations.

Key Accountabilities:

• Facilitate and lead assigned investigations involving multiple investigation areas.
• Work with various departments, including manufacturing, packaging, quality control, maintenance, engineering, and supply chain, to conduct investigations, determine root cause and implement improvements.
• Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause.
• Analyze deviation trends and provide insights for continuous improvement initiatives.
• Ensure that investigations and reports are completed and closed within specified timelines.
• Assess deviation potential impact to product quality for root cause, corrective or preventive actions and impact to product safety, identity, strength, quality or purity.
• Determine the appropriate actions needed to prevent the recurrence of the event and define the criteria for evaluating the CAPA's effectiveness.
• Review, update and approve Standard Operating Procedures (SOPs) and other company documents.
• Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance.
• The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management.
• Prepare and present deviation reports to management and regulatory authorities as the need arises.
• Ensure that documentation is completed following Good Documentation Practices (GDP).
• Support regulatory inspections, internal audits, and customer audits as required.
• Perform additional job-related assignments as requested by management.

Key Requirements:

• Bachelor's degree in science, preferably chemistry.
• 3 years of experience in quality assurance, deviation management, or a related role in [industry, e.g., pharmaceuticals, manufacturing, etc.].
• Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.