SPECIALIST QUALITY

VIVOS HOLDINGS•Smyrna, TN

2d•Onsite

About The Position

The Specialist Quality Microbiologist I role involves prioritizing daily sample testing and performing various microbiological tests on raw materials and finished product batches. This includes identifying, isolating, and studying microorganisms, bacteria, and their byproducts. The position requires investigating Out of Specification (OOS) and Out of Trend (OOT) results, implementing corrective actions as determined by QC Management, and assisting in training new Associates. The microbiology lab is structured into subsections, each responsible for maintaining quality control at different stages of product development, production, and release of finished goods. These areas include Finished Product Testing, Antimicrobial Effectiveness Testing, Environmental Monitoring, and Test Method Validation. At this level, the analyst is expected to independently master the technical skills and knowledge required for one of these areas, including documentation, understanding related questions, and operating autonomously. Additionally, the analyst will support colleagues in other lab areas as needed.

Requirements

Bachelor of Science degree in biology with emphasis in microbiology.
Thorough knowledge of bacterial colony morphology, diagnostic media and rapid methods of organism identification, pathogenic effects of microorganisms, potential environmental contamination factors.
Thorough knowledge of laboratory operations and capability of utilizing scientific judgment to assess problems.
Extensive knowledge of GMPs and USP regulations in reference to microbial testing.
0-1 years in a microbiology lab.
Aseptic techniques.
Gram staining.
Membrane filtration.
Operation of the autoclave.
Serial dilutions.
Standard plate counts.
Work safely with potentially pathogenic microorganisms.
Demonstrated interpersonal skills.
Ability to work well independently and make quick decisions under pressure.

Nice To Haves

Preferred knowledge of Biology, ADI or other rapid method ID systems.

Responsibilities

Prioritize daily sample testing and perform a variety of microbiological tests on raw materials and finished product batches.
Identify, isolate, and study micro-organisms, bacteria, and their byproducts.
Investigate OOS/OOT results and implement corrective actions as determined by QC Management.
Aid in training new Associates.
Maintain quality control at different stages of product development and the production and release of finished goods.
Learn and master technical skills and knowledge required to work independently in one of the lab's areas (Finished Product Testing, Antimicrobial Effectiveness Testing, Environmental Monitoring, Test Method Validation).
Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts.
Perform and document testing in accordance with cGMP.
Organize workload of the laboratory and provide management with feedback on overall laboratory performance.
Coordinate information flow within the laboratory and to internal customers.
Access, input, and retrieve information from QC computer systems.
Disposition of raw materials, process samples, and finished products for use or sale.
Ensure all laboratory documentation meets standards for completeness and accuracy, including documentation of aberrant events and mistakes.
Demonstrate a complete understanding of safe procedures for processing, analyzing, and storage of hazardous and/or flammable products and raw materials.
Work with minimal supervision, re-prioritizing work schedules quickly.
Become familiar and assist with OOS/OOT and Customer complaint investigations.
Become familiar and assist with Method Development Protocols and conduct requisite testing.
Become familiar and assist with SOP creation, review, and revision activities.
Become familiar and assist with the ordering of supplies, services, reagents, organisms, and other consumables in the lab.
Become familiar and assist with instrument maintenance, calibration, and troubleshooting.
Perform any routine task in the laboratory in an efficient manner.
Participate in meetings as required.
Complete training assignments as required.
Perform all other duties as assigned.