Our Cell & Gene Therapy Biotechnology CDMO client seeks a Quality Control Microbiology Analyst II who will serve as a support role to clinical and commercial and perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring. This position reports to the QC Microbiology Manager. 

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

REQUIREMENTS

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

Wednesday-Saturday, 2nd Shift, 2:00pm-12:30am

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.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

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