Microbiology Training Specialist

Summit, New Jersey, US
Closing date
Dec 1, 2021

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Title: Microbiology Training Specialist

Location: Summit, NJ

Start date: ASAP

  • Carry out responsibilities in accordance with the organization's 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 and 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.
  • Experiences on HPLC, UPLC, or GC is plus.
  • Performs general laboratory cleaning/wipe-down.
  • Perform routine maintenance of lab equipment's.
  • 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.

  • Bachelor's Degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Microbiology lab training experience & Master's 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.
  • Endotoxin testing
  • Experience with BAC T or preferred
  • The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment.
  • The incumbent may be required to stand and walk for extended amount of time.
  • The incumbent may be required to work hazardous materials.
  • Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
  • Flexible to work shift structures.
  • Change to work timings and assigned tasks may occur at a very short notice to support business needs.

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.

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