Microbiology Lab Technician (Environmental Monitoring Testing/GMP/LIMS)

Shift: M-F 7am to 4:30pm =, 6am start time one day a week

OT on weekend may required on occasion

The Primary function would be to :

• Performs routine Environmental Monitoring testing within a GMP environment.
• Performs Environmental Monitoring (EM) during a fill operation.
• Supports other lab associated functions.
• Perform test methods as written to support product/material release.
• Effectively perform a multitude of laboratory techniques with minimal error for which they will be trained on.
• Understand, implement, and maintain GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
• Accept responsibility to complete assigned tasks as committed.
• Support investigation writers and approvers to gather data. effectively perform a multitude of laboratory techniques with minimal error for which they are or will be trained on
• Writes or revises procedures with guidance.
• Works under the guidance of a supervisor but is able to manage their own time to ensure timely completion of assigned duties
• Trends data to support trend reports.
• Should be willing to work on weekends and holidays.

Top Skills:

• QC Micro experience- -Hands- on experience with lab testing and EM.
• hands- on Aseptic Technique experience preferable.
• hands- on working experience in Biosafety hoods preferable.
• Attention to detail while running assays/ tasks in the lab and while performing EM is required
• Should have good organizational skills, ability to prioritize workload and extremely thorough with excellent attention to detail.
• Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
• MUST be flexible working weekends and holidays.
• Strong interpersonal / communication skills.
• Maintaining good working relationships within and outside the department.
• Adjusting quickly to new situations.
• Reprioritizing to meet schedule demands in continually changing work environment.
• Knowledge with the LIMS system, specifically entering results is preferred

Nice to have:

• Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH guidelines, cGMP) is preferred.
• GMP and/or Clean-Room experience
• Clean-Room Gowning
• Experience with cGMP documentation and record maintenance is required

Years of experience/education and/or certifications required:

• BS in Biology or other life science required

What are the top 3-5 skills requirements should this person have?

• QC Micro experience- -Hands- on experience with lab testing and EM.
• Attention to detail while running assays/ tasks in the lab and while performing EM is required
• Should have good organizational skills, ability to prioritize workload and extremely thorough with excellent attention to detail.
• Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
• MUST be flexible working weekends and holidays.
• Strong interpersonal / communication skills.
• Maintaining good working relationships within and outside the department.
• Adjusting quickly to new situations.
• Reprioritizing to meet schedule demands in continually changing work environment.
• Must be comfortable standing for most of their shift.
• Shuttling between Client buildings is required.
• Also, must be flexible to work (some) weekends and holidays (pre-scheduled).

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH guidelines, cGMP) is preferred.
• GMP and/or Clean-Room experience
• Clean-Room Gowning
• Experience with cGMP documentation and record maintenance is required
• This job requires to standing for long periods of time
• Experience Level 3-5 Years