QC Analyst III

QC Analyst III, Microbiology

Job ID: req4200
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 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.
• Develops tests to support quality control analysis.
• Prepares documentation for test procedures.
• Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records.
• Assure compliance to in-house and external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
• Perform, microbial analysis of water and product samples.
• Perform qualification of test media.
• Perform required data analysis, compile data and prepare results for review.
• Conduct enumeration of viable air samples, microbial identification, bioburden analysis, and sterility testing.
• Participate in internal assessments and audits.
• Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities.
• Interpret test results, compare to established specifications and control limits and makes recommendations on appropriateness of data for release.
• Perform microscopic techniques.
• Perform wet chemistry testing and spectroscopic testing.
• Implement new equipment following analytical instrument qualification guidance.
• Assist with the administration of electronic data system.
• Perform method qualification/validation activities.
• Responsible for data documentation and technical writing.
• May be required to work 2nd or 3rd shift and weekends as needed to support manufacturing activities.
• Responsible for daily laboratory maintenance tasks.
• Provide occasional utility monitoring and environmental monitoring support.

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 a Biological Science or Chemistry (Qualifying experience (4 years) in directly relevant, experience in a cGMP lab environment 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 five (5) years of progressively responsible experience.
• Must possess basic Microsoft Office skills.
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles.
• Ability to follow SOPs and comply with cGMP regulations.
• Ability to author SOPs, protocols and reports, and technical data summaries with minimal oversight.
• Develop microbiological methods.
• Perform a variety of analyses including some analytical methods (e.g., PCR).
• Experience working in a microbiology laboratory.
• Experience and ability to execute microbiology assay methodologies including enumeration, subculturing, media qualification, microbial identification and bioburden testing.
• Good technical writing skills.
• Experience in data evaluation, trending and troubleshooting.
• Strong proficiency with investigational skills for root cause analysis.
• General knowledge of Biosafety Level 2 (BSL2).
• Aseptic techniques.
• Use of electronic systems.
• Experience with interdepartmental collaboration.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Sterility testing.
• Experience in analytical Instrument qualification.
• Experience in rapid microbial methods.
• Experience addressing non-conformances
• Strong technical writing skills.

PHYSICAL QUALIFICATIONS

• Physical requirements include the ability to maintain balance at all times, walk, hear (corrective appliance allowed), lift/carry up to 25lb, reach above shoulders, climb step ladders/step-stools, push/pull, and stand for extended periods.
• Ability to wear Personal Protective Equipment (PPE).
• Capable of working in a laboratory with potentially hazardous chemicals.
• Ability to Operate and/or service equipment that uses compressed or liquid gas.
• Visual acuity to include depth perception and vision correctable to 20/40.
• Pacemaker prohibited.

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.

74 625.00

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