Sr. QC Associate I (P-4984)

10x Genomics is looking for a Sr. QC Associate I to join our Quality Control team. This role is responsible for the qualification of consumable products associated with Single Cell, Spatial, and In-Situ product lines. In addition to ensuring a reliable supply of quality consumables, you will be a key contributor to the development of manufacturing infrastructure required to support commercial products in the life science field.

The ideal candidate will possess deep working knowledge of chemistry, biochemistry, and analytical methods. You must have extensive hands-on experience working within an ISO-regulated manufacturing environment.

What You Will Be Doing:

• Execute QC Testing: Perform quality control operations according to defined procedures to ensure the integrity and quality of raw materials, intermediates, and finished goods.
• Data Analysis & Disposition: Complete QC testing in a timely manner and disposition materials based on established acceptance criteria.
• Product Development and Sustaining Support: Serve as the primary QC point of contact to oversee project completion, providing expert guidance on assay setup and assisting in the introduction and optimization of new products and processes.
• Assay Cross-Training: Cross-train on various inspections, including first article inspection, metrology, microscopy, analytical assays, and NGS.
• Documentation: Maintain quality control batch records and ensure Good Documentation Practices (GDP) under ISO requirements. Accurately track QC test data, calibration records, and inventory. Draft Work Instructions in collaboration with the Manufacturing Systems & Engineering team.
• Quality Compliance: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.
• Problem Solving: Effectively identify and communicate complications arising from QC testing with minimal supervision. Work closely with scientists to establish and maintain technical solutions. Drive completion of investigations and minimize disruptions to QC operations.

Minimum Requirements:

• 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.

Preferred Qualifications:

• 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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