Senior QC Analyst — Drive Methods & Compliance (Equity)

Alamar Biosciences, Inc.

Fremont (CA)

Sur place

USD 90 000 - 100 000

Plein temps

14 jours+
Générateur de candidature

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Résumé du poste

Alamar Biosciences, Inc. is seeking a Quality Control Senior Analyst to support the full QC lifecycle from raw materials through finish goods and stability.

This role emphasizes method transfer, troubleshooting, deviations, and documentation, in a fast-growing company with ISO 13485/GMP compliance. The ideal candidate has a BS in molecular biology or related field with 5+ years in QC, strong data analysis skills, and a collaborative, process-oriented mindset to improve testing, specifications,

Qualifications

  • BS in molecular biology, biology, or related field with 5+ years in Quality Control or similar environment.
  • Experience in molecular biology techniques.
  • Knowledge of ISO 13485 and GMP environments.
  • Excellent verbal and written communication skills.
  • Statistical analysis knowledge a plus.

Responsabilités

  • Perform analytical/functional testing for materials and finished goods.
  • Analyze data and prepare QC result documentation.
  • Prepare reference standards and assay samples for QC.
  • Review QC test records.
  • Train and mentor lower-level analysts.
  • Update QC documents for compliance and efficiency.
  • Monitor testing data for spec and process improvements.
  • Lead investigations and resolutions of QC nonconformances.
  • Create and execute QC equipment SOPs and validations.
  • Support R&D transfer and test method implementation in QC.
  • Participate in test method validation activities.
  • May assist in other activities as needed.

Formation

BS in molecular biology or related field

Description du poste

Alamar Biosciences, Inc. is seeking a Quality Control Senior Analyst to support the full QC lifecycle from raw materials through finish goods and stability.

This role emphasizes method transfer, troubleshooting, deviations, and documentation, in a fast-growing company with ISO 13485/GMP compliance. The ideal candidate has a BS in molecular biology or related field with 5+ years in QC, strong data analysis skills, and a collaborative, process-oriented mindset to improve testing, specifications,

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