Advanced Assay Office​/Validation Analyst

Position Summary

The responsibilities of this position include all aspects of assay value assignment and assisting with product validation activities. Responsibilities include organizing, analyzing, and evaluating internal and external data for the assignment of assay values comparing selected assay values to release specifications, and compiling validation data for report generation.

• Perform assay value assignment.
• Perform calculations and prepare assay sheet data for entry into assay sheet templates.
• Maintain product history used for value assignments and monitor quality of assay values.
• Maintain knowledge of instrument theory and methodology.
• Write and maintain Assay Office procedures for value assignment and related procedures.
• Collaborate with the Product Validation Manager to write and review validation summaries and reports.
• Review Product Finishing and Laboratory records and complete release documents.
• Maintain Batch Records.
• Prepare COAs for OEM customers and proof COAs/assay sheets as needed.
• Coordinate customer data and QC laboratory testing.
• Assist with calibration decisions for internal laboratory analyzers during whole blood calibration.
• Prepare validation documents per electronic documentation management system protocols and applicable SOPs.
• Collaborate with Quality Assurance and Regulatory Affairs; knowledge of CLSI EP05 and ISO 13485 is desired.
• Maintain confidentiality; follow safety and company policies.
• Perform additional duties as assigned.

• BS in Medical Technology or Biological Sciences (or equivalent with related clinical lab experience).
• 3-5 years of related lab or quality assurance experience.
• Hematology experience preferred.

• Knowledge of laboratory equipment and company procedures.
• Professional customer support; problem solving; independent leadership.
• Plan/organize/multitask; professional oral/written communication; detail-oriented/high accuracy.
• Work independently and in a team; standard business hours.
• Strong data analysis and computer skills;
  Microsoft Word and Excel required; typing/computer entry required.

• Onsite work during standard business hours; occasional schedule variation.
• Ability to work at a computer for extended periods; lift/handle 5-20 lbs.

• Competitive insurance benefits starting day one: medical, dental, vision, life, short-term disability, long-term disability, pet, legal and d.
• 401k, ESPP, HSA, FSA, Dependent Care FSA.
• Tuition reimbursement; mentorship/training/development; paid holidays and accrued leave; paid time off; paid parental leave.