Advanced Assay Office/Validation Analyst

Scorpion Therapeutics; Minneapolis (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Insurance benefits starting day one

401k + ESPP + HSA

Tuition reimbursement and training

Job summary

Scorpion Therapeutics seeks a skilled professional to oversee assay value assignment and support product validation activities in a laboratory setting. You will organize, analyze, and evaluate data to assign assay values and compile validation data for reports.

The role emphasizes maintaining assay value history, ensuring data integrity, and contributing to COA preparation and release documentation in collaboration with QA and Regulatory teams.

Qualifications

• 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.

Responsibilities

• Perform assay value assignment and prepare data for assay sheet templates.
• Maintain product history used for value assignments and monitor quality of assay values.
• Collaborate with the Product Validation Manager to write and review validation summaries and reports.
• Review lab records and complete release documents; maintain Batch Records.
• Prepare COAs for OEM customers and QC data for audits and external data requests.

Skills

Data analysis

Lab data management

Problem solving

Independent leadership

Communication

Multi-tasking

Word & Excel

Education

B.S. in Medical Technology or Biological Sciences

Tools

Microsoft Word

Microsoft Excel

Job description

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.

Key Responsibilities

• 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.

Qualifications

• 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.

Skills/Knowledge

• 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.

Working Conditions/Physical Requirements

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

Benefits (explicitly listed)

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