QA Biologist

Signature Science, LLC; Austin (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Signature Science, LLC seeks a subject matter expert in molecular biology and/or microbiology to support QA contracts focused on CBRNe collection and analysis, and to strengthen internal Signature Science quality programs, including QA audits and ISO 17043 proficiency testing.

The role involves leading external audits, delivering audit reports, assisting with ISO accreditation, reviewing QA data, and developing quality documents.

Qualifications

• 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

Responsibilities

• Provide subject matter expertise in molecular biology/m microbiology for QA of collection or analytical activities.
• Lead external audits of client laboratories and/or sample collection teams, delivering on-site findings and audit reports.
• Provide feedback on auditee corrective actions and assist with accreditation preparations.
• Perform internal audits of Signature Science systems against ISO/IEC standards.
• Review and summarize QA/proficiency test data and contribute to technical reports.
• Develop and revise project quality documents per ISO standards (17025, 17043, 17034, CLIP).
• Provide ISO 17025 training to clients.
• Oversee proficiency test sample prep, method validation/verification, and coordination with external labs.

Skills

PCR methods

Immunoassay

Microbiology lab

Quality management

Audit leadership

MS Office

Communication

Self-starter

Education

Bachelor degree in biology or related field

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Position Purpose:

We are seeking an experienced subject matter expert in molecular biology and/or microbiology to provide technical support to Signature Science's quality assurance (QA) contracts for national and homeland security programs, with a focus on CBRNe collection and analysis efforts. The successful candidate will also support internal Signature Science quality programs, including the Signature Science ISO 17043 accredited Proficiency Testing Program, through auditing, quality management system document development and QA laboratory support.

Essential Duties and 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
• Other activities may include:
  • 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

Required Knowledge, Skills & Abilities:

• 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

Preferred knowledge, skills, and abilities include:

• Hands-on laboratory experience with PCR, immunoassay, and/or microbiological laboratory methods.
• General laboratory management experience.
• American Society for Quality (ASQ) Certified Quality Auditor (CQA) certification, or equivalent;
• Experience with CBRNE applications

Education/Experience:

• 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

Certificates and Licenses:

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

Clearance:

Candidate must be willing to seek and maintain government security clearance at the SECRET level. Applicants with current security clearance are preferred. Candidate must be a U.S. citizen.

Supervisory Responsibilities:

No staff supervisory responsibilities expected; candidate may lead projects or tasks.

Working Conditions/ Equipment:

• Traditional office environments with extended sedentary periods (i.e., desk work)
• Climate controlled laboratory environments requiring extended periods of standing when performing laboratory analyses and/or during audits
• Mobile laboratories, subject to wide ranges of temperature and humidity, and potentially requiring standing, stooping or kneeling in confined spaces
• Conference, classrooms or theaters that involve extended periods of standing for training delivery or command briefings
• Candidate may be exposed to chemical and biological materials associated with an analytical lab or facility, and must be able to to wear required personal protective equipment (PPE) including gloves, coats or gowns, shoe cover, tyvek coveralls, safety glasses, respirators, and/or PAPRs. Candidate may be subject to medical monitoring based on lab functions
• Candidate may be requested to travel up to 50% of the time