Execute QC Testing: Perform quality control operations according to defined procedures to ensure the integrity and quality of raw materials, intermediates, and finished goods. Ensure that lab operations and workflow execution are compliant with ISO requirements. Work closely with scientists to establish and maintain technical solutions. Education: B.S. in Analytical Chemistry, Biochemistry, or a related field. Experience: 5+ years of laboratory experience specifically in a QC environment. Technical Skills: Strong hands-on experience with NGS and tissue-based assays (including immunofluorescence and flow cytometry). Proficiency in PCR, qPCR, spectrophotometry, spectrofluorometry, and HPLC. QC Strategy Setup: Experience collaborating with R&D and QA on risk-based QC strategy assessment including assay robustness, assay cost, and alignment of QC checkpoints to the manufacturing process. Operational Knowledge: A solid understanding of New Product Introduction (NPI) and manufacturing processes. Adaptability: Ability to manage and track diversified QC assays and projects in a rapidly evolving environment. Soft Skills: Strong critical thinking, logical problem-solving skills, and the ability to communicate effectively with stakeholders. Proficiency with data analysis tools (e.g. Retool, Tableau, GitHub, Snowflake). Direct work experience within an ISO 13485 environment. Proficiency with Lean Six Sigma tools and methodologies.
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