Quality EM Technician II

This is an onsite position. Shift: Tuesday-Saturday 8-4:30
(On occasional coming in early or staying late.
Monday thru Friday availability will be needed during first few months of training. Some weekends or Holiday coverage needed, will know in advance.)

Description Details

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.

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. (No Master s Degree or Research candidates.)

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.
• 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.

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