Gmp Quality Associate

vor 2 Wochen

Innsbruck, Tirol, Österreich X-Therma GmbH Vollzeit

X-Therma, a venture backed biotech company pioneers ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, and cell & gene therapies to patients in need with a total addressable market of over $10B.

X-Therma collaborates with renowned research institutions such as Lawrence Berkeley National Laboratory and Johns Hopkins University and is supported with significant funding from the US Department of Defense, National Science Foundation, California Institute of Regenerative Medicine, as well as the FFG Austria.


X-Therma has made a quantum leap in demonstrating significant extension of organ shelf-life from a few hours to a few days in collaboration with a World leading surgical team.

This is a paradigm shift that could make worldwide organ sharing possible and eliminate organ discard.

We are generating revenue in the Cell & Gene Therapy (CGT) field and are currently experiencing exponential growth of commercial partnerships with the top CGT developers.

Immediately, the technology could resolve current bottlenecks in Regenerative Medicine biomanufacturing and processing (TAM $8.8B) and allow "off-the-shelf" living medicines in this hyper-growth space.

Recently, our technology was designated as a Breakthrough Device by the FDA


We have a bold vision to create something great that has never been done before: We are wary of what could go wrong, but obsessed with what can go right.

We are mission-driven, intellectually honest and relentless learners, ambitious, courageous, and extraordinarily persistent. "Giving up" does not exist in our vocabulary.

In our international team, we respect and support each other to get better every day and provide solutions that make the world a better place.

Our European location is in the area of Innsbruck, which is known not only for its beautiful landscape and the quality of life it offers, but also for its high level of innovation and engineering quality and as the home of groundbreaking medical technologies.

At this location, the hardware of our product systems is developed and later produced and exported.

At the same time, the European branch takes over the representation of X-Therma in the European Union and will import and distribute our cryopreservation solutions from the USA.


To build up our European entity in the Innsbruck area, we are looking for a Quality Associate to set up the Quality Control/Assurance Department and prepare for an ISO13485 certification.

You will support for ensuring the quality of the entire process manufacturing, from writing procedures, ensuring the Quality of the production and executing the quality control for each manufacturing batches.

You will ensure all processes and products meet specifications and that products are produced in accordance with GMP requirements.

You will participate in all aspects of the exciting creation of the Quality Systems in close cooperation with our colleagues in our San Francisco HQ.

You will have a great opportunity to contribute to groundbreaking, life-saving products.

You will be part of a team producing, distributing and exporting our novel life-saving storage and transport solutions as well as importing and distributing our unique cryopreservation solutions within a small and supportive team environment.

This role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives within the most urgent priorities.

Tasks

WHAT YOU WILL DO:

  • Write SOP, forms, protocol and work instructions as assigned.
  • Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health, and safety requirements.
  • Prepare and participate in Vendor and internal audits.
  • Review of the production process from Bills of Materials to executed Master Batch Records
  • Support product shipping activities and perform quality related oversight and verifications.
  • Assist in the transition of new products from the R&D phase to production and elaborate "make or buy" options with potential OEMs
  • Be part of the documentation routines on the path to a certified Class II medical device
  • Perform any other tasks/duties as assigned by management.

Requirements:

YOUR PROFILE AND QUALIFICATION:

  • Associates or Bachelor's Degree in medical device industry or equivalent in a related field.
  • Minimum 3 year work experience in ISO13485 regulated environment or similarly regulated area is preferred.
  • Experience with cleanroom settings and productions for hardware (quality or manufacturing) preferred.
  • Experience with quality control environmental monitoring preferred.
  • Intermediate skills in Microsoft Word and Excel are required.
  • Excellent organizational, interpersonal and communication skills (written and oral) required.
  • Ability to take feedback constructively and function in a teamoriented work environ

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