Scientist

• 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.

Qualifications:

• BS in Biology or other life science required
• 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 (some) and holidays (pre scheduled).
• Must be comfortable standing for most of their shift. Shuttling between company's buildings is required
• 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

BS in Biology or other life science required 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 comfortable standing for most of their shift. Shuttling between company's buildings is required 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 (Not required):

• 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

Job Requirement

• Environmental monitoring
• Bioburden
• Bacterial endotoxin test
• BET
• LAL
• Microbial tests
• cleanroom gowning

Environmental monitoring Bioburden Bacterial endotoxin test BET LAL Microbial tests cleanroom gowning