Microbiologist

Specialist Quality Microbiologist

Summary:

Prioritize daily sample testing and perform a variety of microbiological tests on raw materials and finished batches. Identifies, isolates and studies micro-organisms, bacteria and their byproducts. Investigate OOS/OOT results and implement any corrective action as determined by QC Management. Aid in training new Associates.

Essential Duties and Responsibilities:

• Perform and document testing in accordance with cGMP. Testing includes, but is not limited to, finished product analysis and preparatory testing of newly developed products, raw material analysis, and organism identification.
• Maintains inventory levels of reagents, media and stock cultures.
• Troubleshooting, maintenance and calibration of laboratory equipment are expected.
• Organize workload of laboratory and provide management with feedback of overall laboratory performance.
• Work on special projects as assigned or requested.
• Modify SOPs as necessary and ensure that procedures are in place for all tasks within the laboratory.
• Perform general housekeeping duties.
• Coordinate information flow within the laboratory and to internal customers.
• Access, input, and retrieve information from the QC computer systems.
• Disposition of raw materials, process samples and finished products for use or sale.
• Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy.
• Demonstrate a complete understanding of safe procedures for processing, analyzing, and storage of hazardous and/or flammable products and raw materials in accordance with local, state, and federal guidelines.
• Document deviations in performance not anticipated or indicated in test procedures.
• Be or become thoroughly familiar with QC and manufacturing process and work flow, QC retain program and documentation procedures.
• Work with minimal supervision, re-prioritizing work schedules quickly.
• Be proficient in performing traditional plating techniques and routine Celsis analysis.
• 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 supplies/services ordering process.
• Become familiar and assist with instrument maintenance and troubleshooting.
• Must be able to perform any routine task in the laboratory in an efficient manner.
• Participate in meetings as required.
• Complete training assignments as required.
• All other duties as assigned.

Supervisory Responsibilities:

N/A

Education Requirements:

Bachelor of Science degree in biology with emphasis in microbiology.

Experience Requirements:

1-2 years in a microbiology lab. Aseptic techniques, gram staining, membrane filtration, operation of the autoclave, preferred knowledge of Biology, ADI or other rapid method ID systems, serial dilutions, standard plate counts and work safely with potentially pathogenic microorganisms.

Competencies:

• Thorough knowledge of bacterial colony morphology, diagnostic media and rapid methods of organism identification, pathogenic effects of microorganisms, potential environmental contamination factors.
• Has a thorough knowledge of laboratory operations and is highly capable of utilizing scientific judgment to assess problems.
• Has an extensive knowledge of GMPs and USP regulations in reference to microbial testing.

Certificates, Licenses, Registrations:

N/A

Travel:

N/A

Work Environment:

Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb. Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.