VIVEX Biologics
Quality Control Microbiologist II
The Quality Control Microbiologist II is responsible for performing microbiological testing and managing results of incoming raw materials, in-process samples, and final product samples. Review and analyze testing data to ensure internal specifications are in accordance with standard operating procedures requirements. Ensure testing results are accurate, and results are available in a timely manner. Must write and review procedures, reports, and investigations. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements.
Responsibilities
Perform microbiology testing including, but not limited to reading cultures, gram staining, microbial limit test, cell count and cell viability testing, growth promotion testing, and biochemical testing.
Support the environmental monitoring program (EM), Stability Program, and the Dose Audit Program.
Perform microbial characterization including subcultures of samples, gram stain, biochemical testing, and final identification using VITEK 2.
Conduct testing of clean utilities of the facility, including but not limited to performing TOC, pH, and conductivity testing.
Review and analyze test results according to internal standard procedures to ensure proper management, tracking, and disposition of materials and products.
Perform reviews and approval of routine testing documents.
Responsible for reporting and analyzing all variances, errors, and deviations to Quality Management.
Maintain proper documentation and trend analysis of QC test results.
Perform laboratory cleaning and maintenance of equipment.
Maintain the laboratory stock of media, reagents and laboratory supplies.
Lead QC validations and support interdepartmental validations and qualifications that require microbiological testing.
Support write investigations, deviations, and change controls. Manage the implementation of controlled changes and corrective actions.
Participate in the on-call weekend schedule.
Perform other duties as assigned by QC Management.
Qualifications Education/Experience: Bachelor’s degree in science with at least 3-4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.).
Associate’s degree in science with at least 4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.).
Skills: Excellent interpersonal, verbal, and written communication skills; excellent organizational and record-keeping skills; detail oriented with the ability to multi-task in a high-pressure environment; proficiency in Microsoft Office.
Working Conditions Fast paced, lab-oriented work environment. Evening and weekend work may be required.
Physical Requirements Regularly required to sit or stand for prolonged periods of time. May occasionally be required to pull, lift and/or move up to 20 pounds.
Direct Reports No direct reports. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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Responsibilities
Perform microbiology testing including, but not limited to reading cultures, gram staining, microbial limit test, cell count and cell viability testing, growth promotion testing, and biochemical testing.
Support the environmental monitoring program (EM), Stability Program, and the Dose Audit Program.
Perform microbial characterization including subcultures of samples, gram stain, biochemical testing, and final identification using VITEK 2.
Conduct testing of clean utilities of the facility, including but not limited to performing TOC, pH, and conductivity testing.
Review and analyze test results according to internal standard procedures to ensure proper management, tracking, and disposition of materials and products.
Perform reviews and approval of routine testing documents.
Responsible for reporting and analyzing all variances, errors, and deviations to Quality Management.
Maintain proper documentation and trend analysis of QC test results.
Perform laboratory cleaning and maintenance of equipment.
Maintain the laboratory stock of media, reagents and laboratory supplies.
Lead QC validations and support interdepartmental validations and qualifications that require microbiological testing.
Support write investigations, deviations, and change controls. Manage the implementation of controlled changes and corrective actions.
Participate in the on-call weekend schedule.
Perform other duties as assigned by QC Management.
Qualifications Education/Experience: Bachelor’s degree in science with at least 3-4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.).
Associate’s degree in science with at least 4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.).
Skills: Excellent interpersonal, verbal, and written communication skills; excellent organizational and record-keeping skills; detail oriented with the ability to multi-task in a high-pressure environment; proficiency in Microsoft Office.
Working Conditions Fast paced, lab-oriented work environment. Evening and weekend work may be required.
Physical Requirements Regularly required to sit or stand for prolonged periods of time. May occasionally be required to pull, lift and/or move up to 20 pounds.
Direct Reports No direct reports. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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