Top 2 Microbiologist Jobs in Hickory, Nc

Senior Microbiologist
Exela Pharma Sciences —Lenoir, NC
- 5 years
- Bachelor of Science
- Bachelor's degree
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Manager, QC Microbiology
Exela Pharma Sciences —Lenoir, NC
- Master's degree
- Bachelor's degree
- Cleaning
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Senior Microbiologist

Exela Pharma Sciences -
Lenoir, NC

Quick Apply

Job Details

Qualifications

Incident investigation techniques for hazard identification
Defect resolution root cause analysis
Team leadership
Preventive action implementation
Coaching
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
GMP
Internal investigations
Manufacturing facility experience
Sterile field contamination management
Bachelor's degree
Mentoring
Failure analysis
Pharmaceutical manufacturing facility experience

Full Job Description

Position Summary

The Senior Microbiologist serves as a technical leader within the Microbiology laboratory, responsible for advanced microbiological testing, complex troubleshooting, and oversight of laboratory investigations. This role drives scientific rigor and compliance by leading root cause investigations, owning CAPAs, and executing continuous improvement initiatives.

The Senior Microbiologist is a subject matter expert (SME) in Environmental Monitoring (EM), Water for Injection (WFI), and product-related microbiological testing, and plays a key role in mentoring and developing laboratory personnel while supporting cGMP sterile manufacturing operations.

Job Responsibilities

Technical Expertise & Laboratory Leadership
- Serve as a subject matter expert (SME) for microbiological methods, testing techniques, and equipment.
- Maintain training and provide technical guidance to Microbiologists on all microbiological testing including product and water bioburden, endotoxin testing, TOC and Conductivity, sterility, and organism identification.
- Lead and execute complex microbiological testing, method troubleshooting, and atypical result evaluations.
- Evaluate and improve microbiological methods for robustness, compliance, and efficiency.
- Support method validations, verifications, and transfers.
Investigations, CAPAs, & Quality Systems
- Lead and own microbiological deviation and laboratory investigations, including thorough root cause analysis.
- Author and drive corrective and preventative actions (CAPA) to completion against defined timelines, ensuring effectiveness and sustainability
- Act as primary microbiology representative in investigations impacting manufacturing, utilities, or product quality
- Execute microbiological change controls for laboratory and manufacturing processes with technical accuracy
Process Improvement & Continuous Improvement
- Lead process improvement initiatives to enhance laboratory efficiency, compliance, and audit readiness
- Drive risk-based decision making for prioritization
Mentorship & Team Development
- Provide bench-side mentorship, coaching, and technical training to Microbiologists
- Develop training materials and ensure effective onboarding and ongoing competency development
- Act as a resource for troubleshooting and scientific problem-solving for the team
Regulatory Inspections & Audit Readiness
- Serve as the primary microbiology representative during regulatory inspections
- Responsible for ensuring inspection readiness
- Maintain effective communication with inspectors
- Drive actions for successful resolution of audit observations or improvements identified.
This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.

Experience Requirements

Minimum of 5-8 years of related laboratory experience, academic or otherwise
Knowledge of aseptic techniques
Knowledge of cGMP
Experience in activities pertaining to aseptic manufacturing and knowledge of how to maintain an aseptic environment
Demonstrated experience leading investigations, CAPAs, and root cause analysis
Strong leadership, mentoring, and coaching skills
Ability to multi-task, work under pressure with time constraints
Must be flexible and able to adapt to changes in task priority
Excellent communication skills and ability to work independently to complete tasks

Education Requirements

Bachelor of Science (BS) Degree in Microbiology, Biology, or related Life Sciences.

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Senior Microbiologist

Manager, QC Microbiology

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