Shift: M-F
OT on weekend may required on rate occasion
No Masters Degree or Research candidates.
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:
o BS in Biology or other life science required
• What are the top 3-5 skills requirements should this person have?
o QC Micro experience- -Hands- on experience with lab testing and EM.
o Attention to detail while running assays/ tasks in the lab and while performing EM is required
o Should have good organizational skills, ability to prioritize workload and extremely thorough with excellent attention to detail.
o Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
o MUST be flexible working weekends and holidays.
o Strong interpersonal / communication skills. Maintaining good working relationships within and outside the department.
o Adjusting quickly to new situations. Reprioritizing to meet schedule demands in continually changing work environment.
o **Must be comfortable standing for most of their shift. Shuttling between *** 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?
o Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH guidelines, cGMP) is preferred.
o 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
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
