No Masters Degree or Research candidates.
Should be willing to work on weekends and holidays.
Able to work OT on weekends on rare occasions
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
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
- Experience Level = 3-5 Years
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