Lead Auditing QA Specialist

About the role

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 with our company policies/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