QA Specialist II - EVLP

Unither Pharmaceuticals•Jacksonville, FL

6d•Hybrid

About The Position

The QA Specialist II will ensure cGMP compliance, maintain quality systems and support the continuous improvement of existing quality systems related to the manufacture of medical devices and ExVivo Organ Perfusion services. Review documentation (e.g., analytical and medical records, clinical case records, protocols, reports, environmental monitoring data, device design history files, laboratory data) for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and applicable GMP, QSR, and clinical trial requirements. Perform raw material review and inspection, supporting material release decisions in accordance with established procedures and quality standards. Coordinate controlled document collaboration, review, and approval activities to ensure timely and compliant document lifecycle management. Provide real-time review of clinical case data, including occasional 24/7 availability for remote procedure or data review as required. Perform quality assurance activities to ensure compliance with current regulatory standards, including deviation and failure investigations, change control documentation management, complaint handling, standard operating procedures, and product quality reviews. Review, author, and update SOPs and reports to support quality systems. Assist Operations, Quality, and R&D in the preparation of validation protocols and reports, and as assigned, coordinate validation plans and related tasks to support timely execution of validation projects. Assist management during FDA and other regulatory inspections by supporting the timely and accurate transfer of data, documents, and information to inspectors while exercising discretion. Maintain quality files, both electronic and physical, including training records, protocols and reports, environmental monitoring data, cleaning records, and decontamination records to ensure completeness and compliance.

Requirements

Bachelor’s Degree in a related field
3+ years of experience in the biotech, pharmaceutical, medical device, biologics, or related regulated industry
3+ years of experience in Quality Assurance within the GMP/GTP/QSR regulated environment
Applied knowledge of GMPs/QSR, FDA guidelines, and industry standards.
Ability to apply GMP to company specific processes and products in the assessment and preservation of lungs
Experience in review/audit of quality records
Ability to interpret data in relation to a vast number of company procedures as well as current GMP/GLP/GCP/QSR requirements
Excellent professional documentation skills
Ability to objectively, accurately, and thoroughly convey complex issues in writing
Ability to produce a large volume of written materials independently
Exceptional skills in problem and risk analysis and assessments
Ability to interact with other departments effectively
Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures
Ability to handle confidential company data, projects, information, etc.

Responsibilities

Review documentation (e.g., analytical and medical records, clinical case records, protocols, reports, environmental monitoring data, device design history files, laboratory data) for accuracy, completeness, and compliance with Lung Bioengineering policies, procedures, and applicable GMP, QSR, and clinical trial requirements
Perform raw material review and inspection, supporting material release decisions in accordance with established procedures and quality standards
Coordinate controlled document collaboration, review, and approval activities to ensure timely and compliant document lifecycle management
Provide real-time review of clinical case data, including occasional 24/7 availability for remote procedure or data review as required
Perform quality assurance activities to ensure compliance with current regulatory standards, including deviation and failure investigations, change control documentation management, complaint handling, standard operating procedures, and product quality reviews
Review, author, and update SOPs and reports to support quality systems
Assist Operations, Quality, and R&D in the preparation of validation protocols and reports, and as assigned, coordinate validation plans and related tasks to support timely execution of validation projects
Assist management during FDA and other regulatory inspections by supporting the timely and accurate transfer of data, documents, and information to inspectors while exercising discretion
Maintain quality files, both electronic and physical, including training records, protocols and reports, environmental monitoring data, cleaning records, and decontamination records to ensure completeness and compliance