10x Genomics Inc
Sr. QC Associate (Temp to Hire)
10x Genomics Inc, Pleasanton, California, United States, 94566
10x Genomics is looking for a Sr. QC Associate to join its Quality Control team. This is a temp/contract position with a possibility of conversion to a permanent role. This person will be responsible for the qualification of consumable products associated with Spatial and In-Situ products. This person will be a key contributor to the development of manufacturing infrastructure required to support a commercial product in the life science field, as well as to ensuring a reliable supply of quality consumables.
The ideal candidate will have a deep working knowledge of chemistry, biochemistry and analytical methods related to oligonucleotide and antibody conjugation process. Candidates must have extensive hands-on experience working with HPLC, UV-Vis spectrophotometry, spectrofluorometer (plate reader), SDS-Page, mass spectrometry, immunofluorescence, flow cytometry QC assays.
Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution.
What you will be doing
Execute quality control operations according to defined procedures to ensure the integrity and quality of raw material and intermediate parts.Complete QC testing in a timely manner and disposition material based on QC data to the acceptance criteria.Cross train on various assays including metrology, microscope, and NGS assay.Effectively identify and communicate any complications that arise from QC testing with minimal supervision. Ability to work with scientists to establish and maintain a solution.Initiate non-conformance material or deviation report and follow up on progress and action items.Maintenance of quality control batch records and good documentation under ISO requirement.Accurate tracking of QC test data, calibration records, and inventory.Review and validate new QCMs. Revise procedures through ECO process.Assist in the development of processes and products. This includes performing product and process optimization, guard band studies, stability studies, gauge R&R.
Minimum Requirements:
B.S. in analytical chemistry.3+ years laboratory experience in manufacturing or QC for antibody conjugation process.Strong hands-on experience with HPLC, UV-Vis spectrophotometry, spectrofluorometer (plate reader), SDS-Page, mass spectrometry, immunofluorescence, flow cytometry QC assays.Good understanding of new product introduction and manufacturing processes.Able to execute and keep track of highly diversified QC assays.Experience leading and executing on QC projects.Experience acting as a QC representative on cross-functional teams.Detail oriented, quality focused and self-motivated.Flexibility of work schedule to meet the needs of manufacturing.Ability to analyze complex problems including technical failures, instrument failures, and QC method gaps.Desire to be part of a rapidly evolving organization and taking products and processes to the next level.
Preferred Qualifications
Experience in QC strategy set up and new product development.Experience in Lean Six Sigma tools and methods - green/black belt certification.Experience with supporting instrument qualification, PM, and repairs.
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The ideal candidate will have a deep working knowledge of chemistry, biochemistry and analytical methods related to oligonucleotide and antibody conjugation process. Candidates must have extensive hands-on experience working with HPLC, UV-Vis spectrophotometry, spectrofluorometer (plate reader), SDS-Page, mass spectrometry, immunofluorescence, flow cytometry QC assays.
Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution.
What you will be doing
Execute quality control operations according to defined procedures to ensure the integrity and quality of raw material and intermediate parts.Complete QC testing in a timely manner and disposition material based on QC data to the acceptance criteria.Cross train on various assays including metrology, microscope, and NGS assay.Effectively identify and communicate any complications that arise from QC testing with minimal supervision. Ability to work with scientists to establish and maintain a solution.Initiate non-conformance material or deviation report and follow up on progress and action items.Maintenance of quality control batch records and good documentation under ISO requirement.Accurate tracking of QC test data, calibration records, and inventory.Review and validate new QCMs. Revise procedures through ECO process.Assist in the development of processes and products. This includes performing product and process optimization, guard band studies, stability studies, gauge R&R.
Minimum Requirements:
B.S. in analytical chemistry.3+ years laboratory experience in manufacturing or QC for antibody conjugation process.Strong hands-on experience with HPLC, UV-Vis spectrophotometry, spectrofluorometer (plate reader), SDS-Page, mass spectrometry, immunofluorescence, flow cytometry QC assays.Good understanding of new product introduction and manufacturing processes.Able to execute and keep track of highly diversified QC assays.Experience leading and executing on QC projects.Experience acting as a QC representative on cross-functional teams.Detail oriented, quality focused and self-motivated.Flexibility of work schedule to meet the needs of manufacturing.Ability to analyze complex problems including technical failures, instrument failures, and QC method gaps.Desire to be part of a rapidly evolving organization and taking products and processes to the next level.
Preferred Qualifications
Experience in QC strategy set up and new product development.Experience in Lean Six Sigma tools and methods - green/black belt certification.Experience with supporting instrument qualification, PM, and repairs.
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