Senior Analyst, Quality Control

Alamar Biosciences; Fremont (CA); On-site; USD 90,000 - 100,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

Alamar Biosciences is seeking a highly motivated Quality Control Senior Analyst to join our Operations team. You will support all product testing from raw materials through finish goods and stability, including method transfers, deviations, and documentation.

You will lead investigations on QC failures and drive process improvements in a fast-growing environment. The role requires a BS in molecular biology or related field with 5+ years in QC, strong lab skills, and excellent communication.

Qualifications

• A B.S. in molecular biology, biology, or related field with 5+ years of experiences in Quality Control or similar environment.
• Experience in molecular biology techniques.
• Innovative, highly process oriented, detail oriented, organized, and efficient.
• Strong team player and self-starter with the ability to work.
• Excellent verbal and written communication skills.
• Knowledgeable Quality Control process experiences in ISO 13485 and GMP environment.
• Statistical analysis experience a plus.

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.
• Provide technical input and lead investigation and nonconformance on QC testing failures and document resolution.
• Drive and create process change documentation to address testing and specification deficiency as well as process improvement.
• Create/Execute QC Equipment SOP and Validations activities.
• Collaborate/Participate/Assist with R&D and Technical Transfer in test method transfer and drive method implementation in QC.
• Occasional participation in test method validation activities.

Skills

Molecular biology techniques

Quality Control experience

Process orientation

Attention to detail

Communication skills

ISO 13485 / GMP knowledge

Statistical analysis

Education

B.S. in molecular biology or related field

Job description

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.

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. 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. 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. 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.

KEY 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.
• Provide technical input and lead investigation and nonconformance on QC testing failures and document resolution.
• Drive and create process change documentation to address testing and specification deficiency as well as process improvement.
• Create/Execute QC Equipment SOP and Validations activities.
• Collaborate/Participate/Assist with R&D and Technical Transfer in test method transfer and drive method implementation in QC.

OCCASIONAL RESPONSIBILITIES

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

QUALIFICATIONS

• A B.S. in molecular biology, biology, or related field with 5+ years of experiences in Quality Control or similar environment.
• Experience in molecular biology techniques.
• Innovative, highly process oriented, detail oriented, organized, and efficient.
• Strong team player and self-starter with the ability to work
• Excellent verbal and written communication skills.
• Knowledgeable Quality Control process experiences in ISO 13485 and GMP environment.
• Statistical analysis experience a plus.

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.

Please Note - We participate in E-Verify to confirm authorization to work in the United States.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Alamar Biosciences’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

Voluntary Self-Identification of Disability

Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

• Alcohol or other substance use disorder (not currently using drugs illegally)
• Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heart disease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficulty hearing
• Diabetes
• Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
• Epilepsy or other seizure disorder
• Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
• Intellectual or developmental disability
• Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
• Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
• Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
• Partial or complete paralysis (any cause)
• Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
• Short stature (dwarfism)
• Traumatic brain injury