California, US residents click here.
The job details are as follows: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
Minimum 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.
Job Location
This role is based in our Jacksonville, FL office. Currently this job is a hybrid role requiring at least four days per week in the office. In office requirements could increase to five days per week based on business needs.
On-Call Schedule - Expectation to be available 24-hours, 7 days/week, via phone, during team's one-month on-call schedule, which occurs 2 to 3 times per year.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
