QA Biologist

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.
  o Lead or assist with the validation and/or verification of new methods
  o Communicate with external laboratory staff to help resolve QA, PT, or other quality-related issues
  o 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

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 able to obtain a Secret level security clearance.

Supervisory Responsibilities:

N/A

Working Conditions/ Equipment:

• Ability to work in varying conditions to include: traditional office environments with sedentary extended periods required for voluminous data analysis via office automation;
• Climate controlled laboratory environments requiring extended periods of standing when performing laboratory analyses, or during audits and SOP observation;
• Mobile laboratories, subject to wide ranges of temperature and humidity requiring extended periods of standing, stooping or kneeling in confined spaces; conference, classrooms or theaters that involve extended periods of standing for training delivery or command briefings; and outdoors in various weather and lighting conditions including heat, humidity, cold, snow, bright sun, and dark night.
• Exposure to various chemical and biological materials associated with an analytical lab or facility.
• Ability to wear required personal protective equipment (PPE) including gloves, coats or gowns, shoe cover, tyvek coveralls, safety glasses, respirators, and/or PAPRs.
• Subject to medical monitoring based on lab functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.