QC Microbiology Analist I, II, III

Quality Control Microbiology Analytics I, II, III QC Microbiology Analyst I The Quality Control Microbiology Analyst I serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst I 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. This position will report into the Manager of QC Microbiology.

• 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; Assist with routine laboratory testing; Plate reads and incubations
• Shipping of test samples and equipment to contract laboratories for testing
• Complete all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

REQUIREMENTS

• Associates degree in a science or relevant field required; Minimum 0-2 years of experience or equivalent experience. Environmental monitoring or within the biopharmaceutical industry experience preferred.
• Proficient with computer software such as; Microsoft Office
• Strong written and oral communication skills
• 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
• Trained in GxP/GDP, Safety
• The QC Microbiology Analyst I must be able to maintain aseptic behavior within a cleanroom environment for an extended period.
• 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
• 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.

QC Microbiology Analyst II The Quality Control Microbiology Analyst II serves as a support role to clinical and commercial production. 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. This position will report into the Manager of QC Microbiology.

• 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; Minimum 2-4 years of experience with environmental monitoring or within the biopharmaceutical industry.
• GxP/GDP, Safety Trained
• Proficient with computer software such as; Microsoft Office, MODA/LIMS
• Familiarity with ISO and EU standards
• Strong written and oral communication skills
• Technical training ability
• 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
• The QC Microbiology Analyst II must be able to maintain aseptic behavior within a cleanroom environment for an extended period.
• 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. QC Microbiology Analyst III The Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst III will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, 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.

• Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Coordinates data for batch release
• Participation in project/client meetings and communications, providing scientific and technical expertise
• Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols
• Review of investigations and documentation of non-confirming events and environmental excursions.
• Apply expertise of compliance requirements to maintain an inspection-ready state.
• Participate and act as subject matter expert during audits/inspections
• Develop and train QC Microbiology Analyst II on relevant business processes
• Processing of purchase orders for outsourced testing and lab supplies
• Coordinates work orders

REQUIREMENTS

• BA/BS in a science or relevant field required or equivalent experience; Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry
• GxP/GDP Trained
• Proficient with computer software such as; Microsoft Office, MODA/LIMS, Microsoft Visio (preferred), Netsuite (preferred), Maximo Asset Management System (preferred)
• Proficient knowledge of ISO and EU standards
• Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.
• Strong written and oral communication skills
• Strong technical writing skills
• Technical training experience
• 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
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
• 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

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.

Please note these job descriptions are 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.