QC Microbiology Analyst II - Weekend Position

Job ID: req4302
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 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 ensures 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.
• Develop processes and tests to determine that appropriate quality control analysis is being performed.
• Prepares documentation for inspection/testing procedures.
• Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records.
• May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
• The schedule for this QC Analyst II will include weekends with flexibility in desired work week (example, 5 days flexible hours Sat-Wed).
• May be required to work 2nd or 3rd shift or early mornings as needed to support manufacturing activities.
• Performs routine testing of environmental samples, microbial analysis of water and compressed gases, and microbial analysis of product samples.
• Performs required data analysis, compile data and prepare results for review.
• Conducts enumeration of viable air samples, microbial identification, 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, compared 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 a bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in biology, microbiology, chemistry, or similar scientific discipline. (Qualifying four (4) years equivalent, directly relevant, experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, a minimum of two (2) years of job-related experience.
• Must possess basic Microsoft Office skills.
  
• Experience with environmental monitoring and utility monitoring.
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles.
• Ability to generate and follow standard operating procedures (SOPs) and comply with cGMP regulations.
• Working knowledge of a laboratory environment and equipment used for pharmaceutical analysis.
• Experience and ability to execute microbiology assay methodologies including enumeration bioburden testing, 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 REQUIREMENTS

• Physical requirements include the ability to maintain balance at all times, 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.
• The 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.
• Pacemakers are prohibited.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• General knowledge of Biosafety Level 2 (BL2).
• Use of electronic systems E.g., MODA, LIMS.
• Experience with gram staining.
• Experience generating EM trend reports.
• Experience in and ability to perform media qualification testing.

JOB HAZARDS

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

Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

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.

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