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Senior Analyst, Quality Control

Alamar Biosciences ยท Fremont, California
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posted
1d ago
location
Fremont, California
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<div class="content-intro"><p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.</span></p></div><p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">We seek a highly motivated and energetic Quality Control Senior Analyst to join a dynamic team of professionals in the Operations team to support the company mission.&nbsp; This position will be working in the Quality Control team to support all product testing activities from the start of raw material to the final finish good product as well as product stability.&nbsp; In addition, the position will include supporting new test method transfer, assay troubleshooting, deviations/nonconformance resolution, specification optimization, as well as streamlining existing test method procedures and documentation.&nbsp; Seeking a professional Sr. Analyst that is an astute learner with ability to adapt to shifting priorities in a fast-paced and rapid growing company, with strong understanding and adherence to established processes and procedures in compliance with ISO 13485/GMP requirements.</span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>KEY RESPONSIBILITIES</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Perform analytical/functional testing for raw material, in-process/bulk, finish goods, and stability products.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Perform data analysis and generate summary result documentation.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Prepare internal QC reference template standards and assay samples/plates for QC testing.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Review QC test records.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Trainer and SME to lower-level analyst.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Update/Revise QC documents for improvement/compliance/efficiency.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Monitor and trend testing data for improvements on specifications and processes.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Provide technical input and lead investigation and nonconformance on QC testing failures and document resolution.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Drive and create process change documentation to address testing and specification deficiency as well as process improvement.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Create/Execute QC Equipment SOP and Validations activities.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Collaborate/Participate/Assist with R&amp;D and Technical Transfer in test method transfer and drive method implementation in QC.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>OCCASIONAL RESPONSIBILITIES</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Participate in test method validation activities</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">May assist in other activities as needed</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><strong>QUALIFICATIONS</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">A B.S. in molecular biology, biology, or related field with 5+ years of experiences in Quality Control or similar environment.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Experience in molecular biology techniques.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Innovative, highly process oriented, detail oriented, organized, and efficient.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Strong team player and self-starter with the ability to work</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Excellent verbal and written communication skills.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Knowledgeable Quality Control process experiences in ISO 13485 and GMP environment.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 12pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">Statistical analysis experience a plus.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 12pt;">The base salary range for this full-time position is $90,000 - $100,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.&nbsp;</span></p><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: helvetica, arial, sans-serif;" data-olk-copy-source="MessageBody">Please Note - We participate in E-Verify to confirm authorization to work in the United States.</span></p></div>