QC Microbiology Engineer(s) I, III
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
EndotoxinEquipment 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
EndotoxinEquipment 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 processesREQUIREMENTS
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 assignedREQUIREMENTS
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