Lead QA Auditor

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

Position Summary & Role:

The Lead QA Auditor is a site position located in Alachua, FL reporting to the Head of QMS & Compliance.  The primary responsibility of this role is to ensure there an effective external audit support process and lead the internal audit program. 

The Lead QA Auditor leads primary functions and programs for External (Regulatory and Client) Audits and manages and oversees the internal (self) audit program.   

Job Responsibilities:

• Assess the organization to ensure compliance with applicable standards, regulations and guidance

• Coordinate action plans and follow-up with auditees to assure prompt and adequate completion of agreed upon actions

• Review, evaluate and assess documentation to ensure compliance to cGMP, industry standards and other applicable regulations.

• Cross train in departmental duties to assist in meeting the resource needs of the department as assigned

• Schedule, plan, conduct and lead internal and external audits, to include creating and communicating audit plans, agendas, and reports

• Drive investigations, perform root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional subject matter experts

• Monitor and continuously improve the Quality Systems. Perform focused, for-cause and directed audits as requested and necessary

• Independently manage a comprehensive internal audit program and act as lead auditor in accordance with a defined audit schedule

• Act as host to customer, external and third-party audits.

• Act as lead trainer and Subject Matter Expert for FDA or other government agency audit preparedness

• Maintain and author documents (SOPs, WIs, Forms, Records) associated with the audit program to include writing, reviewing, training, and revising as needed

• Assess, evaluate, train, and qualify other auditors within the organization.  Maintain records of all auditors to demonstrate qualification

• Track and trend audit results and provide requested data as needed for management review.

• Position may require travel both domestically and internationally up to 10% of the time.

All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.  

Minimum Qualifications:

• Knowledge of biologics global regulatory requirements (FDA, EMA, PMDA, Health Canada, etc.)

• Demonstrated experience in hosting audits and leading audits

• Excellent communication, organization and customer service skills 

Preferred Qualifications:

• Bachelor’s degree or higher in a science or technical field

• Significant experience in biologics or pharmaceutical QA with strong QA auditing experience

• ASQ Certified Quality Auditor or similar

Physical Requirements:

This job requires the employee to perform the following physical activities:

• Climbing

• Balancing

• Fingering

• Stooping

• Kneeling

• Repetitive motion

• Crouching

• Feeling

• Reaching

• Standing

• Grasping

• Walking

• Pushing 

• Hearing

• Pulling   

• Lifting

• Talking

This job requires the employee to work in the following conditions:

• Temperature changes

• Activities occur inside and outside

This job requires exposure to the following:

• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.

• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.

• Laboratories, production ro