Description
Join our dynamic Quality Assurance (QA) team in our state-of-the-art facility in Munich. We are seeking candidates with an industry background, preferably with experience and knowledge in biological laboratories (e.g. cell and gene therapy), and a strong commitment to managing systems and processes. This role offers an exciting opportunity to maintain and enhance laboratory systems and processes for development laboratories, as well as support the Pharmaceutical Quality System in a GMP environment.
It also presents excellent opportunities for professional development to expand your GMP knowledge and responsibilities in Quality Assurance over the mid-term.Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.
Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
Role Responsibilities:
In this role, you will ensure the integrity of laboratory systems and support the GMP-compliant maintenance of our Pharmaceutical Quality System.
- Maintain and enhance the documentation system for laboratory development operations at the Ascend Munich site including creating and updating procedures
- Oversee and manage the electronic laboratory notebook, collaborating closely with subject matter experts across departments
- Review method-specific procedures created by subject matter experts to ensure compliance with defined Ascend standards
- Facilitate and conduct training sessions for new starters on laboratory documentation and processes
- Support the QA team with maintaining of quality documentation, which includes:
- reviewing and editing documents for format, consistency and compliance with Ascend standards
- issuing controlled copy documents
- maintaining the eQMS
- participating in customer audits
- assisting in the qualification of suppliers
- participating in self-inspections
Requirements
- Bachelor’s Degree in Life Sciences or related field, or equivalent practical experience.
- Experience in laboratory operations, ideally in a GMP environment
- Proactive team player, with focus on quality and timelines.
- Ability to make decisions and to work well autonomously in a fast-paced environment
- Proficiency in Microsoft Office applications and a strong affinity for computerized systems.
- Strong interpersonal and communication skills
- Proficiency in English and German language (verbal and written)
- Working knowledge of GMP guidelines is preferred.
Benefits
- Sodexo staff discounts
- 30 days holiday
- Performance based Bonus
- Standard pension
- More to come as we grow
Company Values:
Aim Higher – Our motto and values.
- Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.
- Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.
- Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.
To embark on this journey, please submit your resume and a cover letter outlining your qualifications, and interest in this role. We at Ascend embrace diversity and do not tolerate discrimination. We enthusiastically anticipate receiving all applications from individuals who align with our vision., While we appreciate all submissions, we'll reach out only to those selected for an interview. Join us as we shape the future together with boundless excitement and limitless possibilities! Thank you for considering joining our team at Ascend.
