- - TX-Austin
- Austin, TX, USA
- Full Time
To provide quality assurance and biological subject matter expertise to support the credibility and defensibility of 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 and quality management system document development.
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, most of which are based on the ISO/IEC 17025 standard
- Provide ISO 17025 (or other quality topics) training to clients
- May perform proficiency test sample preparation laboratory activities, including sample spiking, nucleic acid extraction, PCR analysis, immunoassay analysis, and packaging samples for shipment.
- May lead or assist with the validation and/or verification of new methods
- May regularly communicate with external laboratory staff to help resolve QA, PT, or other quality-related issues
- May serve as a task leader on one or more projects
Required Knowledge, Skills & Abilities:
- Knowledge of PCR techniques
- Knowledge of immunoassay techniques
- Proficiency in MS Word, MS Excel, and MS PowerPoint
- Strong written and verbal communication skills
- Intermediate understanding of ISO/IEC 17025 and ISO/IEC 17043 standards
- Intermediate analytical laboratory auditing experience (demonstrated by CQA certification within six months of hire date)
- Experience with CBRNE applications preferred
- Ability to lead small teams and ensure accurate and timely submission of project deliverables
- 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 or providing quality assurance support to molecular biology and/or microbiological analytical programs
- Laboratory experience with PCR and/or immunoassay methods highly desired
- General quality management experience highly desired
- Experience performing audits desired
- Experience assessing data for trends desired
Certificates and Licenses:
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.
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.
- Candidate must be willing to travel up to 60% of time.
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.