ESR Healthcare
Quality Control cGMP Microbiology Supervisor Allendale, NJ ref
ESR Healthcare, Allendale, New Jersey, us, 07401
Quality Control cGMP Microbiology Supervisor
Location: Allendale, NJ
Compensation:
View Salary
Referral Reward:
$4000
Job Type:
Direct hire
Job Function:
Quality Control
Industry:
Biotechnology
Experience Level:
Mid-senior
Education Level:
Bachelor’s degree
Job Classification:
Technical
Zip Code:
07401
Skills:
Environmental monitoring within the biopharmaceutical industry
Experience Required:
8 years
Relocation Assistance:
No (Local candidate preferred)
Visa Requirement:
Only US citizens and Green card holders, EAD cards
Number of Positions:
1
Pre-Screen Questionnaire:
In which industries have you been responsible for Environmental monitoring in controlled environments?
Please list the names of the Life Sciences or Biotechnology companies you have worked for.
What types of laboratory testing do you typically perform (e.g., Plate reads and incubations, Growth Promotion, Microbial Identifications)?
What are your compensation expectations?
In peak traffic hours, how much time will it take you to commute to 4 Pearl Ct, Allendale, NJ 07401?
Are you currently employed at the recently listed company in your resume? If not, why? If so, why are you looking for a transition?
Job Responsibilities:
Organize and direct staff to meet and exceed cGMP requirements and establish KPI’s while adhering to quality control-microbiological and technical standards.
Provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.
Investigate and document non-conforming events and environmental excursions.
Troubleshoot and recommend process improvements to achieve greater efficiency and meet quality goals.
Interact with other HCATS EM/Microbiology departments to discuss and harmonize best practices, procedures, and processes.
Participate in department and cross-functional meetings.
Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Author and revise Standard Operating Procedures, Work Instructions, forms, and Protocols to reflect current practices.
Perform microbiological and environmental monitoring data review and compile quarterly and annual Environmental Monitoring trending reports.
Provide staff development through feedback aimed at performance development and review.
Qualifications:
BS in Microbiology or relevant field required.
Biotechnology Certificate or cGMP experience preferred.
Minimum of 8 years of experience with environmental monitoring within the biopharmaceutical industry.
Strong knowledge of microbiological test methods, philosophies, method validation, and method transfer.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Proficient with computer software including MS Office, Excel, and MODA.
Supervisory Responsibility:
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the QC Microbiology Associate position.
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Location: Allendale, NJ
Compensation:
View Salary
Referral Reward:
$4000
Job Type:
Direct hire
Job Function:
Quality Control
Industry:
Biotechnology
Experience Level:
Mid-senior
Education Level:
Bachelor’s degree
Job Classification:
Technical
Zip Code:
07401
Skills:
Environmental monitoring within the biopharmaceutical industry
Experience Required:
8 years
Relocation Assistance:
No (Local candidate preferred)
Visa Requirement:
Only US citizens and Green card holders, EAD cards
Number of Positions:
1
Pre-Screen Questionnaire:
In which industries have you been responsible for Environmental monitoring in controlled environments?
Please list the names of the Life Sciences or Biotechnology companies you have worked for.
What types of laboratory testing do you typically perform (e.g., Plate reads and incubations, Growth Promotion, Microbial Identifications)?
What are your compensation expectations?
In peak traffic hours, how much time will it take you to commute to 4 Pearl Ct, Allendale, NJ 07401?
Are you currently employed at the recently listed company in your resume? If not, why? If so, why are you looking for a transition?
Job Responsibilities:
Organize and direct staff to meet and exceed cGMP requirements and establish KPI’s while adhering to quality control-microbiological and technical standards.
Provide oversight of day-to-day activities including adjustment of workflow, test performance, and quality compliance.
Investigate and document non-conforming events and environmental excursions.
Troubleshoot and recommend process improvements to achieve greater efficiency and meet quality goals.
Interact with other HCATS EM/Microbiology departments to discuss and harmonize best practices, procedures, and processes.
Participate in department and cross-functional meetings.
Ensure compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Interact with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Author and revise Standard Operating Procedures, Work Instructions, forms, and Protocols to reflect current practices.
Perform microbiological and environmental monitoring data review and compile quarterly and annual Environmental Monitoring trending reports.
Provide staff development through feedback aimed at performance development and review.
Qualifications:
BS in Microbiology or relevant field required.
Biotechnology Certificate or cGMP experience preferred.
Minimum of 8 years of experience with environmental monitoring within the biopharmaceutical industry.
Strong knowledge of microbiological test methods, philosophies, method validation, and method transfer.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Proficient with computer software including MS Office, Excel, and MODA.
Supervisory Responsibility:
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the QC Microbiology Associate position.
#J-18808-Ljbffr