QC Associate

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. California Applicant Notice ASK Consulting is committed to complying with the California Privacy Rights Act (?CPRA?), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by View email address on click.appcast.io. Fair Chance Employment Notice If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer. To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice andCCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, commercial information, educational background, and other related data. ASK Consulting will use this information solely to facilitate the recruitment process. This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration. #J-18808-Ljbffr