Description of the job:
They are looking for a Team Leader Quality Control Laboratory to fill a key position reporting directly to the Quality Control Manager. You will be responsible for managing the daily operations required for the analytical characterization of the final and intermediate products generated during the manufacturing process.
Your main mission will be to ensure the proper release of analytical test results while maintaining the highest quality standards. He/she will review the documentation associated with each assay (CQMs and records) on time, ensuring the correct traceability of samples and guaranteeing full data integrity.
The Quality Control Team leader will ensure the correct coordination and integration of his team with the other areas of the department such as Environmental Control, Analytical Development and Laboratory Management Support. As part of his/her mission, he/she will report on activities and incidents to the QC and Analytical Development Manager.
The QA Team Leader will work closely with the Environmental Control, Analytical Development and Document Management areas to ensure the smooth running of the daily operations of the department. He/she will coordinate analytical assay execution activities with the USP and DSP Production and Development departments. Coordinate quality system management activities (Deviations, CAPAS and change controls) with the Quality Assurance area. You will maintain contacts with external suppliers and participate in the evaluation of DEMO equipment for the incorporation of new technologies in the department.
Candidate profile:
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- You have a University Degree related to the area of Molecular Biology, Biotechnology, Biomedicine, Pharmacy… They value PhD.
- You have worked at least 3 years in the industry in the life sciences or pharmaceutical area.
- Demonstrable experience in leadership and team management: training, mentoring and supervision of laboratory personnel.
- You have knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- You have a minimum level of English B2 desirable C1.
- You know the biopharmaceutical techniques based on cell and molecular biology such as ELISA, flow cytometry, PCR, cell culture, potency tests (P).
- You are a responsible and rigorous person, orderly and analytical.
- You like to work to achieve the objectives of the team and you are proactive, leading the achievement of results and with a cooperative attitude.
- You work autonomously, knowing how to organize yourself when there is pressure of results and dates with many simultaneous objectives.
- Your orientation to high quality is high (excellence and self-demanding).
- You always show a positive attitude towards change.
- You have good oral and written communication skills.
If you are interested, please send your CV to personas@vivebiotech.com
VIVEbiotech is a Contract Development and Manufacturing Organization (CDMO) with over 20 biotech companies worldwide that have placed their trust in them. They develop and manufacture lentiviral vectors as a European leader working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including haematological and solid cancers, and rare diseases. They are looking for you to be part of their Team!