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Signature Science, LLC · 2 days ago

QA Biologist

Austin, TX

Full-time

Onsite

Senior Level

5+ years exp

Signature Science, LLC is seeking an experienced QA Biologist to provide technical support for their quality assurance contracts related to national and homeland security programs. The role involves serving as a subject matter expert in molecular biology and microbiology, conducting audits, and contributing to quality management systems.

BiotechnologyHealth Care

No H1B

Security Clearance Required

U.S. Citizen Only

Responsibilities

Provide subject matter expertise in the areas of molecular biology and/or microbiology as they pertain to quality assurance of collection or analytical activities

Serve as a Lead Auditor for external audits of client laboratories and/or sample collection teams, providing on-site identification of audit findings, interacting directly with management of auditee organization, delivering an oral out-brief summary of audit findings, and overseeing the development of the written audit report

Provide feedback on auditee corrective actions

Assist client laboratories in preparing for external ISO 17025 accreditation assessments and attend assessments as an advocate for the client laboratory

Perform internal audits of Signature Science systems and procedures against relevant internal or external standards, including audits of the Signature Science Proficiency Test Program against the requirements of ISO/IEC 17043 and internal policies and procedures

Review and summarize quality assurance and/or proficiency test data, provide input and review of technical reports, identify data trends and other issues

Contribute to the development and revision of project quality documents based on the ISO/IEC 17025, ISO/IEC 17043, ISO 17034, and Clinical Laboratory Improvement Program (CLIP) standards, as applicable

Provide ISO 17025 (or other quality topics) training to clients

Perform proficiency test sample preparation laboratory activities, including sample spiking, microbiological analysis, nucleic acid extraction, PCR analysis, immunoassay analysis, and packaging samples for shipment

Lead or assist with the validation and/or verification of new methods

Communicate with external laboratory staff to help resolve QA, PT, or other quality-related issues

Serve as a task leader on one or more projects

Qualification

Molecular biology expertiseMicrobiology expertiseISO/IEC 17025 knowledgeISO/IEC 17043 knowledgeAnalytical laboratory auditingCertified Quality AuditorPCR methodsImmunoassay methodsQuality management experienceMS Word proficiencyMS Excel proficiencyMS PowerPoint proficiencyProactive attitudeTeam leadershipCommunication skills

Required

Knowledge of PCR, immunoassay, and/or microbiological laboratory methods

General quality management experience and familiarity with ISO/IEC 17025 and ISO/IEC 17043 standards

Analytical laboratory auditing experience

Ability to lead small teams and ensure accurate and timely submission of project deliverables

Proficiency in MS Word, MS Excel, and MS PowerPoint

Strong written and verbal communication skills

Proactive, self-starter

Bachelor degree (or higher) in biology or related field

5-10 years of experience performing molecular biology and/or microbiological laboratory methods and/or providing quality assurance support to molecular biology and/or microbiological analytical programs

Certified Quality Auditor (CQA) certification required. This certification must be obtained within 6 months from date of hire

Candidate must be able to obtain a Secret level security clearance