Quality Assurance Associate

Vor 5 Tagen

Schlieren, Schweiz CUTISS AG Vollzeit

CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Its lead product denovoSkin has successfully completed a Phase I clinical trial for the treatment of burns and reconstructive surgeries. Clinical Phase II studies are underway in Europe and Switzerland.

For our Quality Assurance department in Schlieren, Switzerland, we are currently seeking an experienced

**Quality Assurance Associate (f/m/d) 100%**

**Your main duties**
- Ensuring the proactive, phase-appropriate management of a complete and independent Quality Management System (QMS), as well as supporting and preparing for QA compliance readiness during inspections and audits
- Ensuring compliance to codes, standards, regulations, and QMS requirements, including creation/revision of appropriate SOPs
- Managing, preparing and maintaining key QA compliance systems (Deviations, CAPAs, Change Control, Risk analysis, Audits)
- Implementing and executing the activities related to the supplier management process as outlined in the SOPs (including supplier audits)
- Maintaining QA activities in compliance with Swissmedic, EU, and FDA (if applicable) regulations across therapeutic areas
- Participating in the collaboration and negotiations of Quality Agreements with third parties and material suppliers
- Training matrix management
- Preparation, reconciliation and archival of controlled copies for PROD and QC departments

**Your background**

You hold a M.Sc./PhD in a natural science field field (e.g., pharmacy, biology, tissue engineering, biotechnologies, and biomedicine) or a comparable education. Knowledge of medical device regulation is a plus. You gained 1+ years working experience in QA related role in pharmaceutical companies in a wide spectrum of QA activities.

**Desired Skills and Experience**
- Must have work permit in Switzerland
- At least 1 years of experience in QA related role in biopharmaceutical companies (ideally ATMPs) in wide spectrum of QA activities, including active inspection experience Fluent in English both oral and written, German is a plus
- Attention to detail with excellent organizational and record keeping
- Great sense of quality and responsibility
- High level of accuracy and organizational skills
- Demonstrate ability to work independently and efficient
- Self-reliant in determining priorities
- Excellent interpersonal skills and team-oriented attitude
- Proficient in English, German is nice to have and any other languages are a considered a plus

**Place of work**

Grabenstrasse 11, 8952 Schlieren

We offer the unique chance to be part of a young and motivated project team with the vision to change the patients’ quality of life. This interesting and challenging job will give you the opportunity to further develop your working skills in a biotech start-up environment and to get in touch with international partners and clinical trial centers. In summary you can expect:

- A high pace start-up environment
- Flexible working hours in arrangement with the team leader
- Competitive benefit package
- A young and dynamic team
- 26 days of holidays/year

**Are you curious to find out more?**
- One-page motivation letter
- Curriculum vitae
- Copies of degrees and references

by using the following link:
For further information regarding the recruiting process, please contact our HR partner HC Solutions, Annika Danielsson or Alessia Cesari.

Art der Stelle: 100%, Festanstellung

Bewerbungsfrage(n):

- What are your salary expectations (annual salary)?
- What is your earliest possible starting date?

Arbeitsort: Vor Ort

  • Associate Director Quality Assurance Gmp

    vor 2 Wochen

    Schlieren, Schweiz Molecular Partners AG Vollzeit

    **General information**: **Reference **:2024-160 **Information about Molecular Partners AG**: **Position description**: **Position title**: Associate Director Quality Assurance GMP **Job description**: To complete our skilled QA team, we are looking for a highly experienced and motivated GMP QA Expert with experience in Swiss, European and US Regulations...

  • Associate Director Quality Assurance GMP

    vor 2 Wochen

    Schlieren, Zürich, Schweiz Molecular Partners AG Vollzeit

    Position description : To complete our skilled QA team, we are looking for a highly experienced and motivated GMP QA Expert with experience in Swiss, European and US Regulations and Guidelines. In this role, you will be responsible for Molecular Partners' QA activities in GMP. As Associate Director Quality Assurance, you report to the Head of Quality...

  • Associate Director Quality Assurance GMP

    vor 4 Wochen

    Schlieren, Zürich, Schweiz Molecular Partners AG Vollzeit

    Position description : To complete our skilled QA team, we are looking for a highly experienced and motivated GMP QA Expert with experience in Swiss, European and US Regulations and Guidelines. In this role, you will be responsible for Molecular Partners' QA activities in GMP. As Associate Director Quality Assurance, you report to the Head of Quality...

  • Associate Director Quality Assurance GMP

    vor 1 Monat

    Schlieren, Schweiz Molecular Partners Vollzeit

    Associate Director Quality Assurance GMP Position titleAssociate Director Quality Assurance GMPTo complete our skilled QA team, we are looking for a highly experienced and motivated GMP QA Expert with experience in Swiss, European and US Regulations and Guidelines. In this role, you will be responsible for Molecular Partners’ QA activities in GMP. As...

  • Quality Assurance Associate

    vor 4 Wochen

    Schlieren, Zürich, Schweiz CUTISS AG Vollzeit

    CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development ofpersonalized bioengineered skin graft products for the treatment of skin defects. Its lead productdenovoSkinTM has successfully completed a Phase I clinical trial for the treatment of burns andreconstructive surgeries. Clinical Phase II studies are underway...

  • Quality Assurance Associate

    vor 1 Monat

    Schlieren, Zürich, Schweiz CUTISS AG Vollzeit

    CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development ofpersonalized bioengineered skin graft products for the treatment of skin defects. Its lead productdenovoSkinTM has successfully completed a Phase I clinical trial for the treatment of burns andreconstructive surgeries. Clinical Phase II studies are underway...

  • Quality Assurance Associate

    vor 2 Wochen

    Schlieren, Zürich, Schweiz CUTISS AG Vollzeit

    CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Its lead product denovoSkin has successfully completed a Phase I clinical trial for the treatment of burns and reconstructive surgeries. Clinical Phase II studies are underway...

  • Associate Director Quality Assurance GMP

    vor 4 Wochen

    CH-8952 Schlieren Molecular Partners AG Vollzeit

    Position description : To complete our skilled QA team, we are looking for a highly experienced and motivated GMP QA Expert with experience in Swiss, European and US Regulations and Guidelines. In this role, you will be responsible for Molecular Partners’ QA activities in GMP. As Associate Director Quality Assurance, you report to the Head of Quality...

  • Head of Quality Assurance

    vor 3 Wochen

    Schlieren, Schweiz CUTISS AG Vollzeit

    CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Its lead product denovoSkin has successfully completed Phase I in burns patients. Clinical Phase II studies are underway in Europe and Switzerland. CUTISS AG aims at designing...

  • Technical Associate/ Research Associate

    vor 2 Wochen

    Schlieren, Zürich, Schweiz Molecular Partners AG Vollzeit

    General information:Reference :Information about Molecular Partners AG:Founded in 2004 by a group of PhD students as a spin-off from the University of Zurich, Molecular Partners AG is a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 180 highly qualified employees. In order to advance modern...

  • Technical Associate/ Research Associate

    vor 4 Wochen

    Schlieren, Schweiz Molecular Partners AG Vollzeit

    **General information**: **Reference **:2023-140 **Information about Molecular Partners AG**: Founded in 2004 by a group of PhD students as a spin-off from the University of Zurich, Molecular Partners AG is a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 180 highly qualified employees. In order...

  • Research Associate

    vor 2 Wochen

    Schlieren, Zürich, Schweiz Molecular Partners AG Vollzeit

    General information:Reference :Information about Molecular Partners AG:Position description:Position title:Research Associate - Lead Generation (100%)Job description:We are looking for a motivated Research Associate to support our Lead Generation team in research projects in drug discovery.Your tasks will include the following:Development and performance of...

  • Junior Research Associate

    vor 3 Wochen

    Schlieren, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international partner, Roche Glycart AG based in Schlieren ZH, we are looking for a qualified and motivated **Junior Research Associate** for a one year contract. In this role, you will be working across two teams within two different laboratories. One team consists of 4 members and the second consists of 6 members. Both...

  • Regulatory Affairs Associate

    Vor 5 Tagen

    Schlieren, Schweiz CUTISS AG Vollzeit

    CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Its lead product denovoSkin has successfully completed a Phase I clinical trial for the treatment of burns and reconstructive surgeries. Clinical Phase II studies are underway...

  • Associate Manager, Omnichannel Marketing, 100%

    vor 2 Wochen

    Schlieren, Schweiz Biognosys AG Vollzeit

    DEPARTMENT: Product Development & Marketing COMPANY: Biognosys AG LOCATION: Wagistrasse 21 | 8952 Schlieren | Switzerland CONTACT: Arina Klein, (Senior HR Specialist) | Telephone: 0442445018 At Biognosys, we believe that deep proteome insights hold the key to breakthrough discoveries that transform science for better lives. With our versatile portfolio of...

  • QC-QA Specialist _Flow cytometry expert

    vor 2 Monaten

    SCHLIEREN, Schweiz Swiss Bioscience GmbH Vollzeit

    Company Overview:Swiss Bioscience GmbH is a rapidly developing GMP manufacturing biotechnology company based in the Zurich Area, Switzerland. We specialize in the production and banking of human mesenchymal stem cells, catering to the evolving needs of regenerative medicine and biotechnology research.Position Overview:We are seeking a highly skilled Flow...

  • Qc-Qa Specialist _Flow Cytometry Expert

    vor 2 Monaten

    SCHLIEREN, Schweiz Swiss Bioscience GmbH Vollzeit

    Company Overview:Swiss Bioscience GmbH is a rapidly developing GMP manufacturing biotechnology company based in the Zurich Area, Switzerland. We specialize in the production and banking of human mesenchymal stem cells, catering to the evolving needs of regenerative medicine and biotechnology research.Position Overview:We are seeking a highly skilled Flow...

  • Director - Head Process Development

    vor 4 Wochen

    Schlieren, Schweiz Anjarium Biosciences AG Vollzeit

    Anjarium is a privately held, early-stage biotechnology company focused on creating a new class of non-viral gene therapies to deliver more predictable, enduring, and inclusionary ways to tackle genetic disease throughout a patient’s lifetime. The Company’s versatile platform aims to leverage breakthrough science and expertise at the interface of genetic...

  • Director - Head Process Development

    vor 2 Wochen

    Schlieren, Zürich, Schweiz Anjarium Biosciences AG Vollzeit

    Anjarium is a privately held, early-stage biotechnology company focused on creating a new class of non-viral gene therapies to deliver more predictable, enduring, and inclusionary ways to tackle genetic disease throughout a patient's lifetime. The Company's versatile platform aims to leverage breakthrough science and expertise at the interface of genetic...

  • Head of Operational Readiness

    vor 2 Wochen

    Schlieren, Zürich, Schweiz DINAMIQS Vollzeit

    Siegfried DINAMIQS is a Contract Development and Manufacturing Organization (CDMO) based in Schlieren-Zurich, Switzerland, specializing in the manufacturing of viral vector gene therapies.At DINAMIQS we are at the forefront of science and innovation. We help our clients improving outcomes and accelerating their gene therapy projects. We offer a comprehensive...