Senior QC Analyst, GMP/ISO 13485, Data-Driven Testing

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

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.