Lead Auditing QA Specialist

Lonza•Tampa, FL

About The Position

The Lead Auditing QA Specialist plans and organizes audits, including reviewing the organization’s quality management system (QMS), understanding its scope, and identifying potential risks. The role provides leadership and direction in GMP compliance and quality to ensure activities are performed and documented in accordance with company procedures and applicable quality and regulatory requirements, supporting product quality, effectiveness, and safety. The specialist leads audits of products, processes, systems, facilities, and procedures; plans audit objectives, scope, criteria, and schedules; selects audit teams; and ensures audits are completed on time with resources allocated effectively. The role includes conducting opening and closing meetings, interviewing personnel, preparing evidence-based reports, and determining compliance conclusions. The specialist also supports strategic compliance initiatives, identifies improvement opportunities, develops action plans, and works with cross-functional teams on corrective and preventive actions. As a site subject matter expert, the specialist promotes early detection and prevention of compliance issues, reviews audit findings for trends, supports continuous improvement, represents the company in external audits and inspections, and advises on pharmaceutical and healthcare auditing standards and regulations. Additional duties include training and mentoring junior auditors, writing SOPs or related documentation, participating in investigations, recommending process changes, and completing other assignments as requested by management or the QA Manager, Compliance.

Requirements

Bachelor’s degree; a science degree is preferred.
At least 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, including the ability to interact effectively with internal stakeholders and external suppliers.
Strong organizational skills and ability to manage multiple priorities and meet deadlines in a fast-paced environment.

Nice To Haves

A science degree.
Experience in pharma or biotech.

Responsibilities

Plan and organize audits, including reviewing the QMS, understanding its scope, and identifying potential risks.
Lead audits of products and processes to assess compliance with industry regulations and company standards.
Develop audit plans that define objectives, scope, criteria, and schedule.
Select audit team members based on audit complexity and required expertise.
Ensure audits are completed within set timelines and resources are efficiently allocated.
Conduct opening and closing meetings, including explaining audit purpose and scope to top management.
Lead interviews with key personnel at different organizational levels.
Draft evidence-based audit reports and determine final compliance conclusions.
Lead and participate in initiatives to improve compliance with regulatory requirements and standards.
Ensure audits follow the annual audit schedule.
Serve as a site expert in GMP requirements, emphasizing early detection and prevention and subsequent correction of issues.
Identify quality and compliance improvement opportunities and develop action plans.
Collaborate with cross-functional teams to implement corrective and preventive actions.
Review and analyze audit findings to identify trends and areas of concern.
Promote continuous improvement, best practices, and quality and compliance initiatives.
Represent the company in external audits and inspections.
Assess systems, facilities, and procedures for compliance with applicable regulations 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 impacts to product safety, identity, strength, quality, or purity.
Recommend changes to processes and programs.
Perform additional job-related assignments as requested by management, including tasks assigned by the QA Manager, Compliance.