Microbiology Training Specialist

Employer
System One
Location
Edison, New Jersey, US
Salary
Competitive
Posted
Jul 14, 2021
Closes
Jul 28, 2021
Ref
2317120542
Discipline
Biology, Energy
Employment Type
Full time
Salary Type
Salary
Title: Microbiology Training Specialist
Location: Summit, NJ
Start date: ASAP
Responsibilities: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 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 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.

Requirements:Bachelor's Degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Microbiology lab 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.
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.