Lead Auditing QA Specialist

Lonza Group; Tampa (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Lonza in Tampa, FL is seeking a Lead Auditing QA Specialist to oversee the audit program aligned with GMP requirements. You will plan, execute and lead audits of products and processes, draft objective scopes, and deliver evidence-based reports.

Collaboration with cross-functional teams to implement CAPA and improve compliance is essential. You will mentor junior auditors, participate in external inspections, and ensure audits are completed on schedule while upholding Lonza's quality standards

Qualifications

• 5+ years of experience in manufacturing operations, laboratory operations and/or QA.
• Strong understanding of GMP regulations and quality systems requirements for pharmaceutical manufacturing.
• Excellent written and verbal communication skills with the ability to interact effectively with internal stakeholders and external suppliers
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment

Responsibilities

• Lead audits of products and processes for compliance with regulations and standards.
• Conduct opening and closing meetings, draft objectives, evidence-based audit reports, and determine final compliance conclusions.
• Develop an audit plan detailing objectives, scope, criteria, and schedule.
• Lead audit teams based on complexity and required expertise.
• Ensure audits are conducted within timelines and resources are allocated.
• Represent the company in external audits and inspections.
• Identify areas for improvement and develop action plans to address them.
• Collaborate with cross-functional teams to implement corrective and preventive actions.
• Mentor junior auditors and independently write SOPs or related documentation.
• Participate in investigations into root cause and CAPA impacts on product safety and quality.

Skills

GMP compliance knowledge

Quality systems

Strong communication skills

Organizational skills

Stakeholder interaction

Job description

Lead Auditing QA Specialist is responsible for planning and organizing the audit process. This includes reviewing the organization’s QMS, understanding its scope, and identifying potential risks that may need to be addressed during the audit. their leadership, direction, and execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance withour companypolicies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products.

Key Accountabilities

• Lead audits of products and processes to ensure compliance with industry regulations and company standards.
• Conduct opening and closing meetings, draft objectives, evidence-based audit reports, and determine final compliance conclusions.
• Develop an audit plan detailing the audit objectives, scope, criteria, and schedule.
• Select an appropriate audit team based on the complexity of the audit and the expertise required.
• Ensure the audit is conducted within the timelines set and that resources are efficiently allocated.
• Conduct opening meetings with top management to explain the audit’s purpose and scope.
• Lead interviews with key personnel at various levels of the organization.
• Leads and participates in strategic initiatives to improve compliance with regulatory requirements and standards.
• Ensures audits are conducted according to the annual audit schedule.
• Plays an active role within the site as experts in GMP requirements. Strategically focused on early detection and prevention, followed by correction of issues.
• Identify areas for improvement in quality and compliance and develop action plans to address them.
• Collaborate with cross-functional teams to implement corrective and preventive actions.
• Review and analyze audit findings to identify trends and areas of concern.
• Foster a culture of continuous improvement by promoting best practices and driving quality and compliance initiatives.
• Represent the company in external audits and inspections.
• Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance with regulatory requirements and specifications.
• Serve as a subject matter expert on auditing standards and regulations in the pharmaceutical and healthcare industry.
• Train and mentor junior auditors on auditing techniques and best practices.
• Independently write SOPs or associated documentation, as required.
• Participate in investigations into root cause, corrective or preventive actions and impact to product safety, identity, strength, quality, or purity.
• Make recommendations for changes to processes and programs.
• Perform additional job-related assignments as requested by management.
• Other tasks assigned by QA Manager, Compliance.

Key Requirements

• 5+ years of experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.
• Strong understanding of GMP regulations and quality systems requirements for pharmaceutical manufacturing.
• Excellent written and verbal communication skills with the ability to interact effectively with internal stakeholders and external suppliers
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.