QC Microbiology Analyst II

At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

This position will report into the Manager of QC Microbiology. The Quality Control Microbiology Analyst serves as a support role to clinical and commercial production at the Allendale, NJ facility. The QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring.

Essential Functions And Responsibilities

Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.

Responsibilities

Under the direction of the QC Microbiology Manager, responsibilities of the QC Microbiology Analyst II will include but are not limited to:

• Environmental monitoring in controlled environments:
• Non-viable particulate monitoring
• Active viable air monitoring Personnel monitoring
• Surface sampling
• Passive air monitoring
• Equipment monitoring:
• Ensure equipment is in proper working conditions
• Ensure all equipment is properly maintained/calibrated
• Program equipment with proper workflows
• Assist with routine laboratory testing
• Plate reads and incubations
• Shipping of test samples and equipment to contract laboratories for testing
• Produce documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Writing/conducting investigations pertaining to environmental monitoring and testing
• Develop and train QC Microbiology Analyst I personnel on relevant business processes
  
  

Qualifications

• BA/BS in a science or relevant field required or equivalent experience
• Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry.
  
  

Competencies/Candidate Profile

• Proficient with computer software such as
• Microsoft Office
• MODA/LIMS
• Familiarity with ISO and EU standards
• Strong written and oral communication skills
• Technical writing skills
• Technical training ability
• Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities
  
  

Supervisory Responsibility

This job has no supervisory responsibilities.

Minimum Required Training (optional)

• Employment as a QC Microbiology Analyst II is contingent on the ability to obtain a qualified gowning status within 90 days of start date.
• GxP/GDP Training
• Safety Training
  
  

Working Environment

• Must have the ability to work in a team-oriented environment
• Must be able to work during the weekend, holidays and as required by the company
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
• Must have the ability to work with specialized equipment
• Must be able to handle the standard/moderate noise of the manufacturing facility
• This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space
  
  

Physical Requirements

The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.

• The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period.
• Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator
• The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
• This role is sedentary. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
• Gowning proficiency as needed.
• Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
• Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
• Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
  
  

Disclaimer

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Wednesday-Saturday, 2nd shift