QC Microbiology Analyst II

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Job description

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.

The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production at the Allendale, NJ facility. The QC Microbiology Analyst II 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.

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

While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.

Must have the ability to work in a team-oriented environment and with clients

Must be able to work during the weekend, holidays, and as required by the company

Must be able to handle the standard/moderate noise of the manufacturing facility

Physical Requirements

The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period.

Must be physically capable to stand; walk; site; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear.

Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator.

Other Duties

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.

Sunday-Wednesday, 1st Shift