Microbiologist

Location
Bethesda, Maryland
Posted
Jun 11, 2022
Ref
2022-12002
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

We are currently searching for a Microbiologist to provide environmental monitoring services for a facility at the National Institutes of Health (NIH). This opportunity is full-time with MSC and it is on-site in Bethesda, Maryland.

Duties & Responsibilities
  • Conduct viable and non-viable particle count monitoring in Aseptic Processing Facilities across the NIH Intramural Program.
  • Perform laboratory work in a cGMP facility in accordance with cGMP requirements.
  • Coordinate disinfectants and lethality studies.
  • Monitors EM trends and performs EM data analysis (non-viable and viable data) for facilities.
  • Support quarterly personal qualification documentation as a quality control function.
  • Document routine procedures following laboratory and NIH guidelines in accordance with GMP regulations in sterile dosage forms, USP <797>/USP <800>, testing requirements for microbiological procedures, 21 CFR parts 210/211, and other FDA regulations /guidelines.
  • Ensure that sampling equipment is available as needed, properly calibrated and is in working order.
  • Perform preventive maintenance and make repairs or arrange for service.
  • Review and recommend new equipment, schedule demonstrations, and initiate procurement.
  • Coordinate installation, certification, and training for new equipment.
  • Schedule routine EM sampling for Aseptic Processing Facilities.
  • Monitor and maintain EM supplies (EM plate bags, sterile viable sampler heads, non-viable sampler printer paper) for EM and Aseptic Processing Facilities.
  • Coordinate and schedule pickup of media supply with DLM Sterility.
  • Monitor and maintain aseptic settling plate supply for Aseptic Processing Facilities.
  • Create monthly and quarterly EM trending reports for EM data and aseptic settling plates.
  • Perform technical review on EM SOPs, Forms and supporting documents.
  • EM Investigations:
    • Daily monitoring of EM viable results from the sterility lab for non-conforming events and escalate all action level growths.
    • Support investigations and/or provide support for EM related non-conforming events.
    • Schedule EM resampling of all equipment/rooms that had an EM excursion.

 

 

Requirements
  • Bachelor’s degree in Microbiology, Biology, Chemistry, or related scientific field is preferred, but not required.
  • Minimum of one (1) year of experience in environmental facility monitoring.
  • Ability to methodically document technical and analytical processes.
  • Experience with GMP regulations.
  • Strong interpersonal skills to deal effectively with a wide range of audiences.
  • Strong organizational skills and the ability to prioritize complex tasks.
  • Time management and organizational skills to work efficiently and independently or as part of a team.

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.