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Sr. Analyst, Quality Control

Fremont, CA

 

 

 

 

 

About Alamar Biosciences:

At Alamar Biosciences, we’re on a mission to transform the field of proteomics for the early detection of cancer and other diseases. We are creating the world’s most sensitive proteomics platform to unmask the deepest secrets of our proteome. Our fully automated, high throughput platform will empower new biomarker discoveries for early detection and prevention of common diseases. We provide exceptional opportunities for those who have the entrepreneurial spirit, enjoy developing novel technologies and products, and aspire to grow together with the company.

Position Description:

We seek a highly motivated and energetic Sr. Analyst, Quality Control to join a dynamic team of professionals in the Operations team to support the company mission. This position will be working in the Quality Control team, supporting all product testing activities from the start of raw material to the final finished product, as well as product stability. In addition, the position will include supporting new test method transfers, assay troubleshooting, deviations/nonconformance resolution, specification optimization, and streamlining existing test method procedures and documentation. We are seeking a professional Sr. Analyst who is an astute learner with the ability to adapt to shifting priorities in a fast-paced and rapidly growing company, while adhering to established protocols and procedures in compliance with ISO 13485/GMP requirements.

Duties & Responsibilities;

  • Perform analytical/functional testing for raw material, in-process/bulk, finish goods, and stability products.
  • Perform data analysis and generate summary result documentation.
  • Prepare internal QC reference template standards and assay samples/plates for QC testing.
  • Review QC test records.
  • Trainer and SME to lower level analyst
  • Update/Revise QC documents for improvement/compliance/efficiency.
  • Monitor and trend testing data for improvements on specifications and processes.
  • Lead investigation and nonconformance on QC testing failures and document resolution.
  • Drive and create process change documentation to address testing and specification deficiency.
  • Create/Execute QC Equipment Validations activities
  • Assist/Participate in R&D test method transfer.

Occasional Responsibilities; 

  • Participate in test method validation activities
  • May assist in other activities as needed

Qualifications:

  • B.S. in molecular biology, biology, or related field with 4+ years of experiences in Quality Control or similar environment.
  • Experience in molecular biology techniques.
  • Detail oriented, organized, and efficient.
  • Strong team player and self-starter with the ability to work independently.
  • Excellent verbal and written communication skills.
  • Experience in ISO 13485 and GMP environment a plus.
  • Statistical analysis experience a plus.

The base salary range for this full-time position is $90,000 - $105,000 + 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.

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