Collins Consulting
Shift Details
Onsite position. Sunday to Thursday morning shift 9-5:30 PM.
Responsibilities
Perform micro 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.
Core Skills
QC Micro experience- -Hands- on experience with lab testing and/or 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.
Experience with cGMP documentation and record maintenance is required
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.
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
Knowledge with the LIMS system, specifically entering results is preferred
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 Gouning
Experience with cGMP documentation and record maintenance is required
This job requires to standing for long periods of time
Experience Level = 3-5 Years
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Responsibilities
Perform micro 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.
Core Skills
QC Micro experience- -Hands- on experience with lab testing and/or 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.
Experience with cGMP documentation and record maintenance is required
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.
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
Knowledge with the LIMS system, specifically entering results is preferred
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 Gouning
Experience with cGMP documentation and record maintenance is required
This job requires to standing for long periods of time
Experience Level = 3-5 Years
#J-18808-Ljbffr