Quality Control Microbiologist I

 The Quality Control Microbiologist I 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 met in accordance with standard operating procedures requirements. Ensure testing results are accurate, and results are available in a timely manner. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements.

•  Perform microbiology testing including, but not limited to reading of 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
• Responsible for reporting 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.
•  Maintains the laboratory stock of media, reagents and laboratory supplies.
•  Support validations and qualifications that require microbiological testing.
• Participate in audits and inspections, accreditation, and licensing activities as needed.
•  Supports investigations, complaints, and deviations contributing to the formulation and implementation of 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 0-2 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). 
• Associate’s degree in science with at least 2 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). 
• Required/Preferred Experience: Hands on Environmental Monitoring experience in a regulated GMP environment (cleanroom EM, viable/non-viable monitoring, trend analysis, excursions).
• Skills: Excellent interpersonal, verbal, and written communication skills required. 
• Must demonstrate excellent organizational and record-keeping skills. 
• Must be detail oriented with the ability to multi-task in a high-pressure environment. 
• Proficient in Microsoft Office. 

Working conditions

Fast pace, lab-oriented work environment. Evening and weekend work may be required.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee 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 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.

VIVEX Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.