QC Analyst 1 supports quality control testing of biopharmaceutical products within a regulated GMP environment.
Key Responsibilities
- Perform routine and specialized analytical assays (e.g., HPLC, ELISA, PCR) on in-process, release, and stability samples.
- Ensure data integrity and compliance with SOPs, cGMP, and applicable regulatory requirements.
- Maintain analytical instruments, execute basic troubleshooting, and support calibration/qualification activities as required.
- Document testing results accurately in LIMS and lab notebooks.
- Assist with deviations, investigations, and CAPA activities.
- Collaborate with Manufacturing, QA, and Development teams to support safe and effective therapy delivery.
Qualifications & Skills
- Strong working knowledge of laboratory analytical methods and GMP expectations.
- Ability to follow SOPs and maintain rigorous documentation practices.
- Competence with LIMS and controlled laboratory recordkeeping.
- Basic troubleshooting skills for laboratory instruments and assays.
- Attention to detail, commitment to data integrity, and effective cross-functional communication.