Associate Expert Microbiology/ Microbiologist/ Microbiology Technician
Not Disclosed•TemporaryOn-site
location_onRestland Memorial Park, Way of Pope Leo VII, East Hanover, Morris County, New Jersey, 07936, United States
About the Role
This 12-month onsite assignment supports the Quality Control department at our East Hanover, NJ facility. The Associate Expert Microbiology role is designed to ensure the integrity of clinical release strategies through rigorous microbiology and environmental monitoring (EM) testing. You will operate within a GxP-compliant environment, executing precise analytical activities that directly impact product safety and regulatory adherence.
The position requires a hands-on approach to laboratory operations, including maintaining reference standards, managing reagent inventory, and ensuring the cleanliness of working areas. You will play a key role in the laboratory's continuous improvement initiatives, supporting 5S and Lean projects while contributing to method qualification and optimization efforts. Additionally, you will be expected to interface with regulatory agencies during audits and participate in the investigation of Out-of-Specification (OOS), Out-of-Event (OOE), and Out-of-Trend (OOT) results.
Work Schedule & Environment
This role operates on a fixed shift schedule covering daytime hours from 12 PM to 8 PM. The schedule includes working one or both weekend days at least once per month, determined by business needs. The position is strictly onsite, requiring full participation in the laboratory's daily operations and collaborative environment.
Application Instructions
Candidates must possess a BA/BS or MS in microbiology, biology, biochemistry, or a related science, along with 1–3 years of relevant experience in the pharmaceutical, biologics, sterile manufacturing, or medical device industry. Fluency in English and a thorough understanding of cGMP, GDP, and FDA guidelines are essential. Please submit your application with a focus on your technical expertise in microbiological testing and LIMS systems.
Equal Opportunity Employer
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Work location
Work model: On-site
Restland Memorial Park, Way of Pope Leo VII, East Hanover, Morris County, New Jersey, 07936, United States
East Hanover, New Jersey
Key Responsibilities
- check_circlePerform microbiology and environmental monitoring testing to support clinical release strategies
- check_circleExecute testing activities compliantly following SOPs, WPs, and GxP quality policies
- check_circlePeer review and archive analytical data in laboratory documentation systems
- check_circleInterface with regulatory agencies during audits as required
- check_circleCollect and generate data for trend reporting and verify data accuracy
- check_circleParticipate in laboratory cleaning, 5S, and Lean projects to identify process improvements
- check_circleMaintain laboratory controls, reference standards, and reagent inventory
- check_circleSupport OOS, OOE, OOT, and deviation investigations and CAPA implementation
- check_circleSupport method qualification, optimization, and gowning qualification programs
Requirements
- verifiedBA/BS or MS or advanced degree in microbiology, biology, biochemistry, or related science
- verified1-3 years of relevant experience in pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry
- verifiedFluent in English
- verifiedKnowledge of cGMP, GDP, good clinical practices, FDA guidelines, ANSI, ISO, and other industry standards
- verifiedThorough knowledge of microbiological and environmental monitoring test methods
- verifiedKnowledge of LIMS systems
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Frequently asked questions about Associate Expert Microbiology/ Microbiologist/ Microbiology Technician at SPECTRAFORCE
What does a Associate Expert Microbiology/ Microbiologist/ Microbiology Technician at SPECTRAFORCE do?expand_more
A Associate Expert Microbiology/ Microbiologist/ Microbiology Technician at SPECTRAFORCE is responsible for the following: Perform microbiology and environmental monitoring testing to support clinical release strategies; Execute testing activities compliantly following SOPs, WPs, and GxP quality policies; Peer review and archive analytical data in laboratory documentation systems; and Interface with regulatory agencies during audits as required.
What are the requirements for this Associate Expert Microbiology/ Microbiologist/ Microbiology Technician role?expand_more
SPECTRAFORCE is looking for candidates who meet the following requirements: BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or related science; 1-3 years of relevant experience in pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry; Fluent in English; Knowledge of cGMP, GDP, good clinical practices, FDA guidelines, ANSI, ISO, and other industry standards; Thorough knowledge of microbiological and environmental monitoring test methods; and Knowledge of LIMS systems.
Where is the Associate Expert Microbiology/ Microbiologist/ Microbiology Technician role at SPECTRAFORCE located?expand_more
Associate Expert Microbiology/ Microbiologist/ Microbiology Technician at SPECTRAFORCE is based in Restland Memorial Park, Way of Pope Leo VII, East Hanover, Morris County, New Jersey, 07936, United States. This is a on-site role.
Is this Associate Expert Microbiology/ Microbiologist/ Microbiology Technician job remote, hybrid, or on-site?expand_more
SPECTRAFORCE has listed this Associate Expert Microbiology/ Microbiologist/ Microbiology Technician role as on-site.
How much experience is required for this Associate Expert Microbiology/ Microbiologist/ Microbiology Technician role?expand_more
Associate Expert Microbiology/ Microbiologist/ Microbiology Technician at SPECTRAFORCE typically requires 1–3 years of relevant experience at the mid level level.
What skills do you need for the Associate Expert Microbiology/ Microbiologist/ Microbiology Technician role at SPECTRAFORCE?expand_more
Key skills for Associate Expert Microbiology/ Microbiologist/ Microbiology Technician at SPECTRAFORCE include Microbiology; Em Testing; Sops; WPS; Labware; Lims; GMP; and GLP.
What category does the Associate Expert Microbiology/ Microbiologist/ Microbiology Technician role belong to?expand_more
Associate Expert Microbiology/ Microbiologist/ Microbiology Technician at SPECTRAFORCE is part of the it job category on Recrutus.