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ESR Healthcare

Quality Control Microbiology Supervisor Allendale, NJ ref

ESR Healthcare, Allendale, New Jersey, us, 07401


Quality Control Microbiology Supervisor Allendale, NJ ref

About job

Referral reward:$250Job type:Direct hireJob function:Quality ControlIndustry:BiotechnologyExperience level:Mid-seniorEducation level:Bachelor’s degreeJob classification:TechnicalLocation:Allendale, NJZip code:07401Skills:environmental monitoring within the biopharmaceutical industryExperience required:8 YearsRelocation assistance:NoLocal candidate preferredVisa requirement:Only US citizens and Greencard holders,EAD card

Direct hireSkills : Environmental monitoring within the biopharmaceutical industry.

Quality Control Microbiology Supervisor

The QC Microbiology Supervisor organizes, and directs staff to meet and exceed cGMP requirements, establish KPI’s, 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 experienceMinimum 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.

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