QC Associate II (P-4985)

Perform molecular biology techniques, including PCR, next-generation sequencing, microscopy, cell and tissue based assays, and HPLC. Participate in instrument QC workflows, including training to work with mechanical stages and read technical drawings and first article inspection report. Initiate non-conformance, deviation reports, engineering change orders (ECO) and follow up on necessary action items. Ensure that lab operations and workflow execution are compliant with ISO requirements. Assist in root cause investigations for non-conforming lots and contribute to continual improvement efforts. Support process and product development activities, including process optimization, guard band and stability studies, and gauge R&R. B.S. in Biological Engineering, Molecular Biology, Analytical Chemistry, Chemical Engineering, or related discipline. 3 years of relevant laboratory experience in manufacturing and QC of life science products (e.g., PCR, NGS, protein analysis, HPLC). Willingness to rotate through various laboratory and administrative tasks and ability to prioritize workload, and adhere to deadlines. Proficiency in data entry using tools such as Excel, Oracle ERP and LIMS. Demonstrated ability to work both independently and as part of a team. Strong attention to detail, organization, and commitment to quality. Effective communication and observational skills. Excellent critical and logical thinking skills to analyze and troubleshoot issues. Proficiency with data analysis tools (e.g. Retool, Tableau, GitHub, Snowflake) Extensive hands-on experience working within an ISO 13485 manufacturing environment.