Role Summary
Responsible for supporting QC testing for in-process, final product, and stability samples. May assist with documentation, deviations, investigations, and continuous improvement efforts.
Responsibilities
- Perform routine testing of in-process, final product, and stability samples.
- May review GMP documentation and perform data verification.
- Support document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- May train analysts on general job duties.
- Perform other tasks as assigned.
Qualifications
- Ability to accurately and completely understand and follow procedures.
- Apply scientific principles to analytical testing and the proper use of laboratory equipment.
- Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
- Attention to detail and demonstrated organizational skills.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
Education
- Bachelor's degree preferred in science. Associate's degree with equivalent combination of education and work experience may be considered. Netherlands: Bachelor's degree /HLO in (bioanalytical) science preferred. MLO level 4 with equivalent combination of work experience may be considered.
- 0-2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Demonstrated experience with basic laboratory techniques and basic laboratory safety practices.
- Prior experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, aseptic technique) is preferred.