Overview
We are partnered with a biotech company seeking a QC Analyst II to support analytical testing within a GMP-regulated environment. This role involves performing and reviewing routine testing of raw materials, intermediates, and drug substances/products to ensure compliance with quality standards and specifications.
The position requires a balance of collaborative teamwork and independent problem-solving, including troubleshooting analytical methods, supporting method qualifications, and contributing to investigations. You will also play a key role in documentation and supporting the day-to-day operations of the QC function.
Responsibilities
- Perform and troubleshoot analytical testing, including potency assays, qPCR/dPCR, ELISA, and/or flow cytometry
- Review and interpret analytical data to ensure accuracy, integrity, and compliance with GMP standards
- Support method qualification, stability studies, and sample management activities
- Assist with OOS/OOT investigations, deviations, and CAPA activities
- Contribute to the preparation and review of protocols, reports, and quality documentation
- Support laboratory audit readiness and maintain compliance standards
- Train and support junior team members where required
- Contribute to continuous improvement initiatives within the QC function
- Carry out additional duties as needed
Requirements
- Bachelor’s degree in a scientific discipline
- 3–5 years of industry experience in biologics, vaccines, cell and gene therapy, or a related field
- Experience working within a GMP environment and a defined Quality Management System (QMS)
Skills & Experience:
- Hands-on experience with aseptic techniques and relevant analytical methods (molecular biology, cell-based assays, and/or protein/biochemical assays)
- Familiarity with data integrity principles and systems such as LIMS or ELN
- Strong attention to detail with the ability to analyse and interpret data effectively
- Ability to work independently while contributing to a team environment
- Experience supporting documentation such as protocols, reports, or quality records
- Flexible and able to adapt to changing priorities and workloads
