Signature Biologics Jobs (NOW HIRING)

Position Purpose:

We are seeking an analytical chemist to provide quality assurance and scientific subject matter expertise to support the credibility and defensibility of national and homeland security laboratory programs, with a focus on chemical and biological threat detection. The successful candidate will also support internal Signature Science quality programs through auditing and quality management system development and maintenance.

Essential Duties and Responsibilities

• Perform internal audits of client laboratories against internal procedures and external standards such as ISO/IEC 17025 and ISO 9001
• Assist client laboratories in preparing for external ISO/IEC 17025 accreditation audits and attend assessments as an advocate for the client laboratory
• Communicate with external laboratory staff to help resolve QA, PT, or other quality-related issues
• Provide feedback and help prepare auditee corrective actions packets for submission to the accreditation body or certification body
• Provide ISO/IEC 17025 training or training on other quality topics to clients
• Assist with planning chemical analysis proficiency tests for methods such as gas chromatograph mass spectrometry (GC/MS), Fourier transform infrared spectroscopy (FTIR), and Raman. Activities include developing proficiency test plans, evaluating proficiency test data, and generating reports describing results of the proficiency test.
• Serve as a task leader and/or principal investigator on one or more projects
• Plan special studies, evaluate data to identify trends and other issues, and prepare reports
• Develop technical training aids on analytical methods, CBRNE topics, or other quality assurance subjects.
• Contribute to the development and revision of internal and external quality documents based on ISO/IEC 17025, ISO/IEC 17043, ISO 17034, and Clinical Laboratory Improvement Program (CLIP) standards, as applicable
• Perform internal audits of Signature Science systems and procedures against relevant internal or external standards such as ISO/IEC 17025, ISO/IEC 17043, and ISO 17034
• May perform laboratory activities related to the preparation and verification of proficiency test samples, as detailed below:
  • Creation of standards/spiking mixes,
  • Sample production,
  • Sample extraction/dilution, and sample analysis using techniques such as GC/MS, FTIR, and Raman

Required Knowledge, Skills & Abilities

• Experience with GC/MS, FTIR, and/or Raman analytical platforms
• Chemical, biological, radiological, nuclear, and explosives (CBRNE) analytical expertise
• ISO/IEC 17025 Quality management experience
• Laboratory auditing experience
• Proficiency in MS Word, MS Excel, and MS PowerPoint
• Strong written and verbal communication skills
• Proactive, self-starter
• Ability to lead small teams and ensure accurate and timely submission of project deliverables

Preferred knowledge, skills, and abilities include:

• Laboratory experience with percent moisture determination, LC-MS/MS, and/or HPLC-UV
• Experience assessing data for trends
• Knowledge and experience with relevant quality standards, including ISO/IEC 17043, ISO 17034, and/or CLIP

Education/Experience:

• Candidate must have a bachelor's degree in chemistry, biochemistry or related field and 10+ years of experience in a similar role with at least 4 years analytical laboratory experience.

Certificates and Licenses:

Candidate will be required to obtain American Society for Quality (ASQ) Certified Quality Auditor certification and complete formal ISO/IEC 17025 Training.

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