Quality Assurance Specialist.

Company Description

Ori Biotech is on a mission to enable widespread patient access to life-saving cell and gene therapies.

Ori launched IRO®, a next-generation CGT manufacturing platform, as a first step towards achieving this mission. The IRO platform is designed to automate better biology and accelerate therapy development to help make these treatments more affordable and widely available to patients.

Scientific breakthroughs continue to be made in cell and gene therapy across a wide range of diseases, including cancer and rare genetic diseases. Despite these advancements, it is estimated that more than 95% of patients who could benefit from this new class of life-saving therapies are left without access.

The challenge is that these transformative treatments are difficult and expensive to manufacture due to the high cost of goods and low throughput limiting the ability to meet patient demand.

This is where Ori Biotech comes in. Our team of leading gene therapy and life sciences veterans are working in collaboration with industry partners to develop innovations that deliver exceptional biology while reducing the time and cost to develop and manufacture cell therapies, to help enable widespread patient access to life-saving cell and gene therapies.

With the commercial launch of IRO®, Ori is in a rapid growth phase backed by some of the top VCs in the US and UK. We are looking for trailblazers, visionaries and the naturally inquisitive; those who can challenge and those who can inspire at this very exciting time.

This is an excellent time to join our world-class team and to be an integral part of changing history by helping to ensure patient access to CGT treatments.

Job Description

We are seeking a Quality Assurance Specialist to join our team and support our ISO 13485 quality management system. The ideal candidate will be a self-starter with critical analytical skills and attention to detail, capable of document control, record management, and implementation of QMS procedures. The successful candidate must have knowledge of CAPA, nonconformance, SCAR, and change control processes, as well as the ability to work collaboratively with others and take initiative.

Key Responsibilities

• Authorship in QMS in an ISO 13485 environment.
• Provide critical analytical skills to help identify potential quality issues and take corrective actions.
• Work collaboratively with others to ensure effective communication and successful outcomes.
• Monitor and analyse quality data to identify trends and opportunities for improvement.
• Provide support to CAPA, nonconformance, SCAR, and change control processes.
• Demonstrate proactivity in identifying and resolving quality issues.
• Continuously seek out opportunities for growth and development to enhance knowledge of quality management practices.

Experience

• Minimum 2 years of experience in a quality management role within an ISO 13485 environment or Pharmaceutical GMP environment.
• Experience in writing procedures from scratch.

Skills

• Knowledge of quality management processes, including CAPA, non-conformance, SCAR, and change control.
• Strong analytical and problem-solving skills with the ability to make sound decisions based on data analysis.
• Detail-oriented with strong organizational skills and ability to prioritize tasks and meet deadlines.
• Excellent communication skills, both verbal and written.
• Ability to work effectively with others and build positive working relationships.
• Self-motivated with a desire to learn and take initiative.

Contract Type: Permanent