Blackwomenintech
Associate Specialist, Quality Operations Environmental Monitoring
Blackwomenintech, Rahway, New Jersey, us, 07065
Job DescriptionPosition Description: Associate Specialist, Quality Operations Environmental MonitoringSpecific to Environmental and Utility Monitoring, the analyst will be responsible for maintaining the EM program to include the following:Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gases.
Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling.
Provide data entry, review and approval as required.
Provide summaries of test results to appropriate personnel as needed.
Compile and evaluate environmental data for adverse trends.
Directly support Performance Qualification activities.
Perform routine monitoring of Personnel and compile and author Annual Reviews as required.
Author and summarize Re-qualification, Performance Qualification, and Special Study protocols as required.
Perform monthly and weekly sample accountability.
Submit LIMS sample rejections.
Filing data sheets and document control of logbooks.
Other duties requested by Management.
In addition, the candidate selected for the Environmental Monitoring (EM) position will be responsible for reading EM Sampling (Microbial Air, Surface, Particulates), EM Plates Processing, TOC analysis, Conductivity, Nitrates, Compressed Gas Testing, GLIMS, SAP.Shift:
Available for shift work, 4 10-hr shifts (Wednesday - Saturday 6:00 am - 4:30 pm), 1st shift. Additional off shift tasks may be required (i.e., Weekend/Holiday / off shift days support).Education Minimum Requirement:Bachelor Degree of Science in Biology, Microbiology, Chemistry, or similar field of study.Required Experience and Skills:At least 1 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.Evidence of good oral and written communication skills (i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills).Attention to detail, flexibility and an awareness of production and attendant quality control problems.Strong understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.Ability to sit, stand and move within work space for extended periods.Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.Ability to lift up to 50 pounds.Preferred Experience and Skills:Quality Control, Quality Assurance and/or cGMP experience.US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Shift:
1st - DayJob Posting End Date:
11/11/2024Requisition ID:
R320264
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Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling.
Provide data entry, review and approval as required.
Provide summaries of test results to appropriate personnel as needed.
Compile and evaluate environmental data for adverse trends.
Directly support Performance Qualification activities.
Perform routine monitoring of Personnel and compile and author Annual Reviews as required.
Author and summarize Re-qualification, Performance Qualification, and Special Study protocols as required.
Perform monthly and weekly sample accountability.
Submit LIMS sample rejections.
Filing data sheets and document control of logbooks.
Other duties requested by Management.
In addition, the candidate selected for the Environmental Monitoring (EM) position will be responsible for reading EM Sampling (Microbial Air, Surface, Particulates), EM Plates Processing, TOC analysis, Conductivity, Nitrates, Compressed Gas Testing, GLIMS, SAP.Shift:
Available for shift work, 4 10-hr shifts (Wednesday - Saturday 6:00 am - 4:30 pm), 1st shift. Additional off shift tasks may be required (i.e., Weekend/Holiday / off shift days support).Education Minimum Requirement:Bachelor Degree of Science in Biology, Microbiology, Chemistry, or similar field of study.Required Experience and Skills:At least 1 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.Evidence of good oral and written communication skills (i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills).Attention to detail, flexibility and an awareness of production and attendant quality control problems.Strong understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.Ability to sit, stand and move within work space for extended periods.Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling.Ability to lift up to 50 pounds.Preferred Experience and Skills:Quality Control, Quality Assurance and/or cGMP experience.US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Shift:
1st - DayJob Posting End Date:
11/11/2024Requisition ID:
R320264
#J-18808-Ljbffr