Position Purpose: To provide quality assurance and scientific subject matter expertise to support the credibility and defensibly of national and homeland security programs, with a focus on chemical and biological threat collection and analysis efforts. The successful candidate will also support internal Signature Science quality programs through auditing and quality management system development and maintenance. Essential Duties and Responsibilities:
- Provide subject matter expertise in the following areas as they pertain to quality assurance of collection or analytical activities: CBRNE threats;
- Molecular biology, microbiology, chemistry, and radiochemistry;
- Quality assurance standards such as ISO 9001, ISO/IEC 17025, ISO 17034, ISO/IEC 17043, DoDI 6440.02 Clinical Laboratory Improvement Program (CLIP).
- Analytical methods including gas chromatograph mass spectrometry (GC/MS), Fourier transform infrared spectroscopy (FTIR), electrochemiluminescence (ECL), polymerase chain reaction (PCR).
- 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 developing written audit reports
- Provide feedback on auditee corrective actions
- Assist client laboratories in preparing for external 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
- Evaluate 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 releveant standards including ISO/IEC 17025, CLIP, and others
- Provide Quality Asssurance and other tehcnical training to clients
- Plan and implement chemical and/or biological proficiency tests for methods such as GC/MS, FTIR, RAMAN, PCR, Immunoassay, etc. Activities may include developing proficiency test plan, performing laboratory pilot testing, preparing and verifying proficiency test samples, and packaging samples for shipment.
- Lead or assist with the validation and/or verification of new methods
- 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 and immunoassay techniques and/or knowledge of GC/MS and FTIR techniques.
- Proficiency in MS Word, MS Excel, and MS PowerPoint
- Strong written and verbal communication skills
- General quality management experience, preferably in an analytical laboratory setting
- Knowledge and experience with releveant quality standads, including ISO/IEC 17025 and ISO/IEC 17043
- Analytical laboratory auditing experience
- Ability to lead small teams and ensure accurate and timely submission of project deliverables
- Proactive, self-starter
- Experience with CBRNE applications preferred
- Laboratory experience with PCR, immunoassay methods, GC/MS, FTIR, LC-MS/MS, HPLC-UV, and/or RAMAN highly desired
- Knowledge and experience with DoDI 6440.02 CLIP and ISO 17034 desired
- Experience assessing data for trends desired
Education/Experience:
- Bachelor degree (or higher) in biology, chemistry, or related field
- At least 10 years of experience performing analytical biology (molecular or microbiological) or analytical chemistry laboratory methods, and/or or providing quality assurance support to 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: May serve as a task leader, Principal Investigator, and/or Project Manager on one or more projects. Working Conditions/ Equipment:
- Candidate must be able to work in varying conditions to include:
- 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 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.
- 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 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.
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