The Quality Assurance Auditor is primarily responsible for planning and executing internal quality audits in a cGMP manufacturing environment. This role will also assist in planning and executing routine external audits of our approved vendors and service providers.

Qualifications

• Communicate audit results to management and auditees through written audit reports.
• Conduct on-site audits of plasma centers to ensure compliance with organizational, state, federal and other laws and guidelines (cGMP, OSHA, IQPP, ISO requirements and regulations).
• Draft and issue periodic reports to site management as requested.
• Lead post-audit activities and follow up on corrective and preventive actions.
• Manage the assessment and identification of potential supplier issues and risk while communicating supplier audit assessment information to supply chain and quality management.
• Perform audits in accordance with our standard operating procedures and quality policies and according to the approved audit plan.
• Perform internal audits of all departments at Boca Raton, FL facility that are directly involved with activities described in the cGMPs or have an impact on activities described in the cGMPs.
• Read, analyze and identify issues in data quality, to include source documents and data files by reviewing processes in comparison to written standard operating procedures and cGMP regulations.
• Schedule, prepare, and conduct quality audits within the commercial, cGMP drug substance and drug product manufacturing facility.
• Assist in external audit activities for our approved vendors and service providers as required.
• Assist with hosting regulatory facility inspections by acting as a scribe, document reviewer or any other supporting role.
• Assist with training and orientation for new Quality Auditing staff.

Education Requirements:

Bachelor's degree preferred in a field related to the title of the position. Other proven experience may be considered in lieu of degree. Professional Auditing Certification preferred (ASQ CQA, CBA, ISO, RABQSA Auditor).

Experience Requirements:

Minimum of five years of related experience in the Biotech/Pharmaceutical industry.

Two to five years of audit experience in a GMP environment preferred.

Experience working with SOPs, GDP, GMP, CLIA, FDA in the Biotech/Pharmaceutical industry or within another highly regulated industry.

Direct experience in supplier and/or internal auditing preferred.

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station