Lead Auditing QA Specialist

Lonza Biologics, Inc.; Tampa (FL); On-site; Confidential; Full time

Job summary

Lonza Biologics, Inc. in Tampa, FL is seeking a Lead Auditing QA Specialist to plan and drive the audit program, review QMS, and identify risks requiring mitigation to assure GMP compliance. You will lead audit teams, draft objective-driven reports, and ensure documentation meets regulatory standards.

You will mentor junior auditors, collaborate with cross-functional teams, and represent Lonza in external audits and inspections to uphold product quality and safety.

Qualifications

• Bachelor’s degree in science required or equivalent experience.
• 5+ years in pharma/biotech QA, manufacturing operations or labs.
• Strong knowledge of GMP regulations and quality systems.
• Excellent written and verbal communication with stakeholders and suppliers.
• Good organizational skills and ability to manage multiple priorities.

Responsibilities

• Lead audits of products and processes to ensure compliance with regulations and standards.
• Conduct opening/closing meetings, draft objectives, and prepare evidence-based audit reports.
• Develop audit plans detailing objectives, scope, criteria, and schedule.
• Select audit team based on complexity and expertise.
• Ensure audits run on time and resources are allocated efficiently.
• Lead interviews with personnel at various levels and represent the company in audits.
• Identify improvements, develop action plans, and drive CAPAs with cross-functional teams.
• Review findings for trends and concerns, promoting best practices.

Skills

GMP compliance

Auditing leadership

Quality systems

Regulatory awareness

Effective communication

Documentation skills

Education

Bachelor’s degree in science

Job description

Lead Auditing QA Specialist

Tampa, FL

Summary

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

• Bachelor’s degree, science degree preferred
• 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.