QC Microbiology Engineer(s) I, III

Job Description

Job Description

Quality Control Microbiology Engineer(s) I, II, III Quality Control Microbiology Engineer I The “Quality Control (QC) Microbiology Engineer I” will support two local sites serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of QC Microbiology, responsibilities of the QC Microbiology Engineer I will include but are not limited to: Microbiological Testing:

• Growth Promotion
• Microbial Identification
• Sterility Testing
• Gram Stain
• Endotoxin

Equipment Monitoring:

• Ensure equipment is in proper working conditions
• Ensure all equipment is properly maintained/calibrated
• 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
• Training in GxP/ GDP, Safety
• Minimum 0-2 years of experience or equivalent experience.
• Microbiology testing or within the biopharmaceutical industry experience preferred.
• Proficient with computer software; 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
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels
• Must be able to work during the weekend, holidays and as required by the company
• Duties, responsibilities, and activities may change at any time with or without notice.

QC Microbiology Engineer II The Quality Control Microbiology Engineer II will support two local sites serving as a support role to clinical and commercial production. The QC Microbiology Engineer II will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer II will include but are not limited to: Microbiological Testing:

• Growth Promotion
• Microbial Identification
• Sterility Testing
• Gram Stain
• Endotoxin

Equipment Monitoring:

• Ensure equipment is in proper working conditions
• Ensure all equipment is properly maintained/calibrated
• 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 microbiological testing
• Develop and train QC Microbiology Engineer 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 microbiological testing or within the biopharmaceutical industry.
• Training in GxP/GDP, Safety
• 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
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.
• 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
• Occasionally personal protective equipment may be required including lab coat, latex gloves, safety glasses and/or respirator.
• Duties, responsibilities, and activities may change at any time with or without notice.

QC Microbiology Engineer III The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the QC Microbiology Engineer III will include but are not limited to:

• Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Coordinates microbiological testing 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 Engineer II on relevant business processes
• Processing of purchase orders for outsourced testing and lab supplies
• Coordinates work orders
• Other duties as assigned

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
• Minimum required training; GxP/GDP Training, Safety Training
• 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
• Supervisory Responsibility; Direct reports
• 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, liquid nitrogen and noise levels.
• 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