Quality Control Analyst
About the role:
Are you passionate about pharmaceutical quality control with a focus on either physicochemical analysis or molecular biology? Join our team as a QC Analyst and contribute to the development and manufacturing of life-changing gene therapies.
You’ll be part of an innovative environment where excellence, collaboration, and continuous learning are at the heart of everything we do.
In this role, your mission will be to ensure that physicochemical or molecular biology assays are performed accurately, while maintaining compliance with Good Manufacturing Practices (GMP) and helping to deliver the highest-quality products to patients.
Key Tasks:
- Perform physicochemical or molecular biology assays for batch characterization, stability studies, comparability or compatibility studies and other testing activities within defined timelines and in accordance with established procedures.
- Perform assays to support the development, qualification, and validation of physicochemical or molecular biology analytical methods.
- Maintain accurate, detailed, and organized records of all testing activities, ensuring data integrity.
- Report any deviations or OOS, OOE, or OOT results to the relevant QC Lead.
- Assist in drafting protocols, reports, SOPs, and related documentation.
- Identify opportunities to improve analytical methodologies and laboratory documentation, proposing updates to enhance consistency and regulatory compliance.
- Actively participate in laboratory maintenance and cleanliness, as well as in the inventory management and expiry-date monitoring of critical reagents and laboratory supplies.
- Collaborate with team members to troubleshoot issues and improve QC processes.
- Support internal and external audits.
Key Working Relationships:
- Quality departments
- Manufacturing departments
- R&D departments
Requeriments
- Education: Higher Vocational Training Diploma in Laboratory Analysis and Quality Control, Manufacture of Pharmaceutical Products, or a related field; or a university degree in Biochemistry, Molecular Biology, Biotechnology, or a related field.
- 1-2 years of previous experience in a quality control role within the pharmaceutical or biotechnology industry is preferred.
- Familiarity with analytical techniques relevant to either molecular biology or physicochemical quality control of gene therapy products, such as qPCR, dPCR, cell culture, or HPLC, is desirable.
- English proficiency sufficient to perform departmental activities (minimum B1 level).
- GMP: Knowledge of GMP requirements or experience working in a highly regulated industry is desirable.
- Organizational and planning skills: Ability to set goals and priorities when performing a task, defining the actions, deadlines, and resources required.
- Continuous improvement mindset: Ability to promote a culture of innovation and learning by contributing ideas and continuous improvements.
- Results orientation: Ability to direct all actions towards achieving the expected outcomes.
- Excellent communication and interpersonal skills, with the ability to work collaboratively across teams.
- Ability to work in a fast-paced environment and manage multiple tasks effectively.
- Alignment with company values: Integrity, Innovation, Collaboration, and Accountability.
