QC Associate

Bristol Myers Squibb; Bothell (WA); On-site; USD 94,000 - 101,000; Full time

Job summary

Bristol Myers Squibb is seeking a QC Flow Cytometry Systems Scientist to act as the SME for FCS Express data analysis templates in GMP QC flow cytometry testing. The role designs, develops, validates, maintains, and manages templates used for product release and assay validation.

The candidate will lead complex technical projects, ensure data integrity, and drive improvements to analytics workflows, collaborating with QC, IT, and QA to uphold regulatory compliance.

Qualifications

• Bachelor's degree in biology or related scientific discipline with 6 years of GMP experience.
• Expertise in flow cytometry analysis and assay lifecycle management.
• Experience creating or editing FCS Express templates.

Responsibilities

• Independently design, build, revise, and qualify templates for all test methods including complex multi-target CAR assays.
• Architect complete gating strategies for new test methods and troubleshoot gating discrepancies.
• Define and validate authorization architectures and data integrity controls.
• Lead template qualification testing and act as SME for FCS Express program.
• Support regulatory inspections and internal audits related to templates.

Skills

FCS Express templates

GMP data integrity

Gating strategies

Boolean formulas

Technical communication

Cross-functional collaboration

Education

Bachelor's degree in biology or related field with 6 years GMP experience

Tools

FCS Express

Job description

• The QC Flow Cytometry Systems Scientist serves as the SME for FCS Express data analysis templates supporting GMP QC flow cytometry testing. This role designs, develops, qualifies, supports validation, maintains, and manages templates used for product release, stability, characterization, method transfer, and assay validation.
• The scientist independently leads complex technical projects, makes risk-based scientific decisions, provides technical leadership for data analysis workflows, ensures compliance with regulatory and data integrity requirements, and drives improvements that enhance robustness, efficiency, and consistency of flow cytometry analysis.

• The QC Flow Cytometry Systems Scientist serves as the SME for FCS Express data analysis templates supporting GMP QC flow cytometry testing. This role designs, develops, qualifies, supports validation, maintains, and manages templates used for product release, stability, characterization, method transfer, and assay validation.
• The scientist independently leads complex technical projects, makes risk-based scientific decisions, provides technical leadership for data analysis workflows, ensures compliance with regulatory and data integrity requirements, and drives improvements that enhance robustness, efficiency, and consistency of flow cytometry analysis.

Duties/Responsibilities FCS Express Template Development & Configuration

• Independently design, build, revise, and qualify templates for all test methods including complex multi-target CAR assays; lead template program documentation and revisions; manage the full template lifecycle from design through archival
• Design multi-page layout architecture; configure complex biexponential scale parameters across populations; optimize plot display for non-standard or analytically challenging datasets
• Architect complete gating strategies from scratch for new test methods; define and validate all parent-child gate relationships across multi-page layouts; troubleshoot and resolve gating discrepancies across replicates and populations
• Design sophisticated custom token systems including multi-condition IF/THEN/ELSE chains, nested custom token dependencies, compound N/A logic spanning multiple replicates, and dynamic batch file naming conventions; verify all formula outputs are mathematically and logically correct
• Define authorization architecture across all object types for new templates; ensure design enforces data integrity and meets regulatory requirements
• Develop alert frameworks for new test methods; define scientifically justified thresholds in collaboration with QC, ASAT, and method development teams
• Design complete batch processing systems for new templates including folder logic, action configurations, server path structure, and dynamic file naming conventions; validate correct file export under all branching conditions
• Define and assign layout-level security groups for new templates; advise QC Management on user access levels
• Template Qualification & Program Ownership
• Lead all qualification testing and review activities; author and maintain controlled configuration documents; serve as Business System Owner and SME for the FCS Express template program
• Support regulatory inspections, internal audits, and document control activities related to FCS Express templates
• Maintain expert-level knowledge across all flow cytometry method panels and marker sets; advise on FMO control strategy, atypical population analysis decisions, and statistical configuration for any flow cytometry test method

Qualifications Specific Knowledge/Skills/Abilities

• Advanced FCS Express proficiency: Ability to build and revise templates, tokens, permission rules, alerts, authorizations, and batch actions.
• Formula and logic skills: Strong ability to create and troubleshoot Boolean formulas, IF/THEN/ELSE logic, nested calculations, and custom token expressions.
• Flow cytometry expertise: Deep understanding of multicolor panels, compensation, FMO controls, gating hierarchy, biexponential scaling, MFI, %CV, and result reporting.
• GMP qualification knowledge: Ability to define, execute, and document template qualification activities in a regulated GMP environment.
• Data integrity and compliance: Strong knowledge of ALCOA , electronic records/e-signatures, audit trail review, and controlled documentation requirements.
• Computerized system experience: Familiarity with validated systems, CSV concepts, user access administration, and network file management.
• Technical communication: Strong written and verbal communication skills to explain technical findings to QC, QA, IT, and management stakeholders

Education/Experience/Licenses/Certifications

• Bachelor?s degree in biology or related scientific discipline with 6 years of GMP experience, or equivalent combination of education and experience.
• Demonstrated expertise in flow cytometry analysis, assay lifecycle management, and complex technical problem solving.
• Demonstrated experience in FCS Express template creation and/or revision strongly preferred
• Experience leading cross-functional projects and influencing scientific decisions.
• Strong understanding of qualification, validation, and computerized system lifecycle principles.

Collaboration & Communication

• Serve as technical resource on FCS Express template development, troubleshooting, and GMP documentation
• Collaborate with flow cytometry SMEs on test method requirements that drive template design decisions
• Partner with IT on FCS Express software maintenance, user access management, and template file administration
• Engage QA/Compliance as needed for escalation of audit trail discrepancies or deviations identified during template qualification or data review

Reporting Relationship

• This position will report to QC management.

100% Onsite!

M-F; Standard Hours!

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb.

The starting hourly compensation for this assignment is the following range ($68- $72.54/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.

About ASK Consulting

ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.

Benefits

• ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.

Equal Opportunity Employer

ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.

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