QA Deviation Investigator

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 & Responsibilities

This role is accountable for supporting the quality management system and requirements for Deviations, CAPAs, Change Controls, Lab Investigations, etc.  This role serves as the quality approver for minor and major records, author of critical records, and assures the Quality Management System (QMS) and method lifecycle is compliant, well-organized, effective, and phase appropriate. This role is the technical lead within Quality Operations in support of activities of Quality Control, Manufacturing, Engineering, and Supply Chain.  This role takes the lead for many of the responsibilities listed below and represents the quality organization and department in client-facing activities at a tactical and strategic level.  This role reports to the Director of Quality Assurance and is site-based at the Alachua facility.

• Independently supports as a quality approver in the QMS for Change Controls, Deviations, Lab Investigations, OOSs, CAPAs, and Risk Assessments.
• Works with initiators, investigators, and stakeholders to ensure change controls and investigations are initiated, performed, and closed within the required timelines.
• Reviews CAPA investigation reports to assess the appropriateness of the identified corrective and preventive action(s) and CAPA effectiveness.
• Provides support in the preparation for, the conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits.
• Sterile gowning required to perform activities on the manufacturing floor including, but not limited to critical process observations, investigation support, and routine GEMBA walks.
• Ensures quality activities are carried out according to regulatory and quality requirements.
• Participate in applicable network communities of practices and share best practices across the network as well as lead and/or support site and network initiatives.
• Client interactions – QMS record and Change Control Notification to Clients, joint working sessions on investigations and technology transfers, and other client-facing responsibilities.
• Review and approval of product and process-related change controls (including Supplier Change notifications) and production documentation.

Minimum Qualifications

• Progressive responsibility in Quality Control, Quality Systems, or Quality Assurance roles in the pharmaceutical or biopharmaceutical industry.
• Hands-on experiences with management of Quality System Processes such as Change Control, Deviation, and CAPA
• In-depth knowledge of Good Manufacturing Practices (cGMP), Quality Management Systems, and applicable industry regulatory requirements
• Experience and knowledge of cGMP and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry
• Excellent oral and written communication skills with strong technical writing experience

Preferred Qualifications

• Bachelor's degree or higher in Life Sciences discipline
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
• Track record of driving a quality mindset with stakeholder groups and establishing expectations and processes to maintain a standard of quality assurance and compliance
• Formal training and experience as a trainer, author, and approver for root cause analysis, problem-solving techniques, and technical writing
• Experience with supporting regulatory inspections

This position may also include the following conditions:

This role is primarily a Sedentary role. This can include exerting up to 10 pounds of force to move objects.

Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, general observations of facilities, etc.

Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing)

Use of personal protective equipment (which can include resp