QC Analyst II, Microbiology

Job ID: req4226

Employee Type: exempt full-time

Division: Vaccine Clinical Materials Program

Facility: Frederick: G-WAY

Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

Program Description

The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

Key Roles/Responsibilities

• Evaluates and implements protocols and methods to inspect and test in-process, raw materials, and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution.
• Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary.
• Prepares documentation for inspection/testing procedures.
• May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
• May be required to work 2nd or 3rd shift, early mornings and weekends as needed to support manufacturing activities.
• Performs routine testing of environmental samples, microbial analysis of water and compressed air/gasses, and microbial analysis of product samples.
• Performs required data analysis, compile data and prepare results for review.
• Conducts enumeration of viable air samples, bioburden analysis, and media qualification.
• Participates in internal assessments and audits.
• Plans own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.
• Interprets test results, compare to established specifications and control limits.
• Performs microscopic techniques/cell counting, utility sampling, environmental monitoring.
• Performs wet chemistry testing.
• Will be responsible for data documentation and technical writing.
• Will be responsible for daily laboratory maintenance tasks.
  
  

Basic Qualifications

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) ) in a scientific related field or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of two (2) years of related experience.
• Basic Microsoft Office skills.
• Experience with environmental monitoring.
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles.
• Ability to generate and follow standard operating procedure (SOPs), and comply with cGMP regulations.
• Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis.
• Ability to execute microbiology assay methodologies including enumeration, gram staining microbial limits and the ability to subculture.
• Good technical writing skills.
• Experience working in a pharmaceutical testing environment.
• Ability to obtain and maintain a security clearance.
  
  

Physical Qualifications

• Physical requirements include the ability to always maintain balance, walk, hear (corrective appliance allowed), arms and legs, lift/carry up to 25lb, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods.
• Ability to respond to verbal instruction and cues in a sterile environment where staff are wearing face masks.
• Ability to wear Personal Protective Equipment (PPE).
• Capable of working in a laboratory or mechanical space and with potentially hazardous materials.
• Ability to operate and/or service equipment that uses compressed or liquid gas.
• Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
• Pacemaker prohibited.
  
  

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• General knowledge of Biosafety Level 2 (BL2).
• Analytical equipment qualification.
• Use of electronic systems E.g., MODA, LIMS.
• Experience with utility sampling/testing.
• Experience with gram staining.
• Experience and knowledge of traditional and rapid microbial methods.
• Experience with microbial identification using a genetic analyzer.
• Experience generating EM trend reports.
• Experience in and ability to execute bioburden testing, sterility testing and media qualification.
  
  

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.
  
  

Commitment to Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

56,200.00 - 96,625.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

#readytowork

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions