We are currently seeking a skilled Biotechnology Quality Specialist to join our team. This is an exciting opportunity for individuals who want to work in a fast-paced environment and make a real difference.
About the Role:
* This role involves working closely with our laboratory team to ensure that all products meet the required standards of quality and purity.
* The successful candidate will have strong analytical skills and be able to interpret complex data from various sources.
Key Responsibilities:
* Achieving high levels of competency in laboratory methods and procedures to support in-process and release testing of biotechnology products.
* Reviewing and approving laboratory test results, ensuring they meet ICH, USP, and EP guidelines.
* Executing validation, operation, maintenance, calibration, and troubleshooting of equipment and its associated software.
* Writing/executing reports and reviewing IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
* Ensuring QC activities are carried out in compliance with product license commitments, cGMP, and company quality standards.
* Providing training to other QC analysts in laboratory methods and procedures when required.
* Writing/ updating and reviewing TMs, SOPs, and WIs as required.
Requirements:
* BSc (Honors) in a scientific/technical discipline, such as biochemistry or chemical engineering.
* 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
* HPLC, Capillary Electrophoresis, UPLC/Mass Spec experience.
What We Offer:
* A competitive salary package and comprehensive benefits.
* Ongoing professional development and training opportunities.
* A collaborative and dynamic work environment.