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Quality Control cGMP Microbiology Supervisor Allendale, NJ ref
Location:
US-NJ-Allendale - 07401
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Quality Control cGMP Microbiology Supervisor Allendale, NJ ref

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Compensation:
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Referral reward:$4000Job type:Direct hireJob function:Quality ControlIndustry:BiotechnologyExperience level:Mid-seniorEducation level:Bachelorís degreeJob classification:TechnicalLocation:Allendale, NJZip code:07401Skills:environmental monitoring within the biopharmaceutical industryExperience required:8 YearsRelocation assistance:No
Local candidate preferredVisa requirement:Only US citizens and Greencard holders,EAD cardsNumber of positions:1

Pre screen questionnaire:

1. In which industries have you been responsible for Environmental monitoring in controlled environments?

2. Please list name of the Life Sciences or Biotechnology companies you have worked for.

3. Tell us types of laboratory testing you typically perform e.g. Plate reads and incubations, Growth Promotion, Microbial Identifications

4. What are your compensation expectations?

5. In peak traffic hours, how much time will it take you to commute to 4 Pearl Ct, Allendale, NJ 07401?

6. Are you currently employed at the recently listed company in your resume? If not, why? If so, why are you looking for a transition?

The QC Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPIís, while adhering to quality control-microbiological and technical standards. Provides oversight of day to day activities including adjustment of workflow, test performance, and quality compliance.

Essential Functions and Responsibilities

Investigate and document non-confirming events and environmental excursions.
Troubleshoot and recommend process improvements to achieve greater efficiency ad meet quality goals.
Interact with other HCATS EM/Microbiology departments on a regularly scheduled basis to discuss and harmonize best practices, procedures and processes between the sites.
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. Compile and issue quarterly and annual Environmental Monitoring trending reports.
Provide staff development through feedback aimed towards performance development and review.
Qualifications

BS in Microbiology or relevant field required.
Biotechnology Certificate or cGMP experience
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 with 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 following positions. Directly supervised the QC Microbiology Associate.

jonathan thompson
esr
confidential
San Diego, CA 92126

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