Senior Quality Assurance Associate
Location
Stevenage, Hertfordshire | United Kingdom
Job description
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Senior Quality Assurance Associate
Apply locations Stevenage, United Kingdom time type Full time posted on Posted 2 Days Ago job requisition id JR1523
Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.
We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!
Purpose:
Support the Quality Assurance Manager in establishing and maintaining compliance of the Quality processes and documentation to meet the requirements of the notified bodies.
Tasks and responsibilities:
- Support with the establishment and continuous improvement of the Quality Management System (QMS)
- Ensure the maintenance of all QMS aspects, such as Change Controls, Non-Conformities, CAPAs, and Deviations.
- Provide all relevant QA support required by the Operations teams, w hich will also involve being present in the cleanroom facilities while batches are being manufactured.
- Conduct internal audits, self-inspections, walk-throughs, and assist with on-site audits of external suppliers as needed.
- Contribute to personnel training on all QMS-related matters.
- Support the collection and reporting of monthly Quality KPIs.
- Develop and implement SOPs, as well as other QA-related documentation.
- Participate in Continuous Improvement (CI) activities and projects through challenging current working practices t o enhance efficiency and quality standards.
What Is Important To Us:
- A degree (or equivalent) in a life sciences (or related) field.
- At least 2 – 3 years’ experience in Quality within sterile manufacturing, ideally within the field of Biologics (preferably ATMPs but not essential).
- Exhibit collaboration with internal departments (Manufacturing, QC, Supply Chain) and external stakeholders across quality and compliance aspects.
- Possess strong communication skills, adept at engaging with both internal and external stakeholders, acting as a credible interface, managing expectations, and addressing intricate challenges.
- Display initiative and a proactive approach in executing plans and delivering objectives.
- Possess a problem-solving mindset.
What We Offer :
- Employment in a company that offers real added value and manufactures medicines for seriously ill patients.
- To be part of the ATMP growth and success story, participating in the development of a great company culture based on teamwork, empowerment and opportunity for personal growth.
- A holiday entitlement of 28 days plus public holidays.
- Flexible working conditions
- An above market pension provision increasing with length of service.
- Private medical health care and benefits scheme.
- Plus other additional benefits.
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