Qc Scientist
2 weeks ago
**Job Title**: QC Scientist
**Location**: Noida, Uttar Pradesh
**Department**: Quality Control
**Company Overview**:
Advancells Group is a leading biotech company specializing in stem cell and exosome manufacturing. We are focused on cutting-edge research and development in regenerative medicine and cell therapy. With a highly collaborative team of dedicated professionals, we are committed to advancing innovative healthcare solutions.
**Position Overview**:
We are seeking a highly skilled and motivated QC Scientist to join our dynamic Quality Control team. The QC Scientist will play a key role in ensuring that our products, specifically stem cells and exosomes, meet the highest quality standards. This role involves rigorous testing, validation, and documentation of manufacturing processes, as well as ensuring compliance with regulatory requirements.
**Key Responsibilities**:
- Perform quality control testing for stem cell and exosome products, including raw materials, intermediates, and finished products, to ensure compliance with internal and external quality standards.
- Develop, validate, and optimize QC testing methods for stem cells, exosomes, and associated materials.
- Conduct routine analysis of cell cultures, characterization of exosomes, and biomolecular assays.
- Prepare and review detailed reports on analytical testing, deviations, and investigations.
- Ensure adherence to GMP, GLP, and other relevant regulatory standards for quality control and documentation practices.
- Work closely with R&D and Manufacturing teams to identify and resolve product quality issues and support product development and process optimization.
- Assist in the preparation of QC protocols, SOPs, and technical documentation.
- Monitor and maintain laboratory equipment and instrumentation, ensuring they are calibrated and functioning optimally.
- Support audits and inspections from regulatory authorities and ensure compliance with all applicable quality systems.
- Contribute to continuous improvement initiatives within the QC department.
**Qualifications & Experience**:
- M.Sc. or Ph.D. in Life Sciences, Biotechnology, Biochemistry, or related field.
- Minimum of 4-6 years of experience in quality control or laboratory testing in the biotech or pharmaceutical industry, preferably in stem cell research or exosome manufacturing.
- Hands-on experience with cell culture techniques, characterization of exosomes (e.g., nanoparticle tracking analysis, Western blotting, qPCR, etc.), and other molecular biology techniques.
- Strong understanding of GMP, GLP, and other regulatory requirements related to quality control in biotech manufacturing.
- Proficient in analytical laboratory techniques, data analysis, and troubleshooting of complex experimental results.
- Excellent attention to detail and strong organizational skills.
- Strong communication skills, both written and verbal.
- Ability to work independently as well as collaboratively in a team environment.
**Desirable Skills**:
- Experience with stem cell biology, regenerative medicine, or exosome therapeutics.
- Knowledge of advanced analytical techniques such as flow cytometry, ELISA, and microscopy.
- Familiarity with data management systems and laboratory information management systems (LIMS).
- Certification or training in quality management or regulatory compliance (e.g., ISO 9001, ISO 13485, or ICH Q7).
**Job Types**: Full-time, Permanent
**Benefits**:
- Provident Fund
Schedule:
- Day shift
Work Location: In person
Expected Start Date: 01/12/2025
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