Associate Scientist Qc Release
vor 2 Wochen
What you will be doing:
The Quality Control department is involved in the validation and transfer of various test methods as well as in performing of routine release and stability tests for novel clinical phase materials as well as ENVM and CVAL samples. The chemical methods applied in-house range from RP, SEC, IC methods, TOC, Conductivity, and a broad range of biochemical methods as SDS-PAGE, Capillary Electrophoresis etc. are applied.
What impact you will also have:
- Work according to the general guidelines, procedures and processes in the QC in accordance with internal regulations.
- Be compliant with general guidelines, procedures and processes in the QC in accordance with the internal rules. This includes all steps of the analysis under cGMP from the sample collection point to the release of the results by the authorized person.
- Help to build a strong team to expand, strengthen and the maintain the current knowledge base and expertise within QC to reflect changing business needs
- Adhere to all applicable regulations, policies, and procedures for health, safety and environmental compliance.
- Perform timely and cost effective testing of samples at required cGMP level resulting from operational activities, stability programs and monitoring
- Create and process ETS records if needed, and support investigations when required
- Maintenance, care and GMP-compliant handling of the devices and technical aids used in the QC. In particular, the devices in the area of responsibility, which are needed for the conduct of the tests, including coordination of dates for maintenance and calibration
- Write technical reports and documents if needed
- Perform laboratory duties to support department objectives
- Periodic review and evaluation of analytical assays (cGMP) according to given timelines if needed
- Contributing to the validation and verification of analytical methods
- Work in a clean and tidy manner to be ready for inspection at all times
- Obtain the necessary materials and reagents for the assigned tests, including ordering laboratory consumables and reagents in the appropriate systems
- Assists in and drives achievements of departmental goals and commitments, regardless of obstacles.
- Support implementation of new equipment in the QC Release & Stability team (Author TRG, provide User input etc.)
- Drive continuous improvement projects within Quality Control in operational efficiency and GMP compliance
- Training of employees and coordination of employee qualification and re-qualification
- Additional tasks can be given by the teamleader
- Delivery on annual goals & objectives, guided by Our Credo and Leadership Imperatives
- KPI, release and stability testing performed in defined time period
- KPI, release and stability no overdue ETS record
**Qualifications**:
We would love to hear from you, if you have the following essential requirements:
Education & Experience:
- Profound working understanding of laboratory operations and practices
- University degree in natural sciences, applied sciences or equivalent
Skills & Competences:
- Good communication abilities
- Time and self-management
- Good language skills in German and English, written and spoken
- Analytical thinking and problem solving abilities
What type of mark will YOU make?
Diversity, Equity & Inclusion at Johnson & Johnson means "YOU belong"
For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued, and every one of our people feels that they belong and can reach their potential. No matter who they are.
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