Microbiology Training Specialist

System One
Summit, New Jersey, US
Jul 30, 2021
Aug 02, 2021
Biology, Energy
Employment Type
Full time
Salary Type
Title: Microbiology Training Specialist

Location: Summit, NJ

Start date: ASAP

  • Carry out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
  • Follow directions properly, work cooperatively as an individual contributor and as a team member.
  • Communicate effectively with QC peers, cross-functional peers and management.
  • Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
  • Train Bacterial Endotoxin and Sterility Testing.
  • Train growth promotion testing of microbiological media.
  • Train mycoplasma testing via PCR.
  • Train Environmental Monitoring on routine basis.
  • Train microbial isolation techniques and perform Gram stain identifications.
  • Train Send out samples to contract labs and track results/reports
  • Performs general laboratory cleaning/wipe-down.
  • Perform routine maintenance of lab equipments.
  • Under the guidance of management, support special project work.
  • Maintain lab inventory and order lab supplies and materials.
  • Support continuous improvement projects related to QC
  • Assist with investigations &CAPAs associated with Microbiological testing.
  • Support data trending and tracking of results.
  • Perform all other duties as assigned.

  • Bachelors Degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Microbiology lab experience & Masters Degree strongly preferred. An equivalent combination of experience/education is acceptable.
  • Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
  • Good knowledge of Microsoft Word and Excel.
  • Responds to challenges and additional projects in an understanding, positive, and objective manner.
  • Adaptable to dynamic conditions, work practices, and project timelines.
  • Ability to multitask, prioritize workload and interpret data accurately.
  • Able to communicate effectively with GDPO functional areas and external agencies.
  • Fosters teamwork and promotes an environment that motivates others to achieve our goals.
  • Experiences on HPLC, UPLC, or GC is plus.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.