SPECIALIST QUALITY

POSITION SUMMARY: Prioritize daily sample testing and perform a variety of microbiological tests on raw materials and finished product 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.

The microbiology lab is divided into subsections; the responsibilities of these areas align with maintaining quality control at different stages of product development and the production and release of finished goods. These areas are as follows:

• Finished Product Testing
• Antimicrobial Effectiveness Testing
• Environmental Monitoring
• Test Method Validation

At the level of a Specialist Quality Microbiologist I, the analyst will be expected to learn and master the technical skill and knowledge required to work independently in one of the areas listed above. This includes documentation, being well versed enough to speak on questions related to the area in question and being able to operate independently of other employees. Additionally, the analyst is expected to assist individuals working in other areas of the lab on an as needed basis.

FUNCTIONS OF THE JOB:

• Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts.
• Presence at work on time when scheduled is a mandatory function.
• Compliance with all company safety rules, procedures, and guidelines is mandatory.
• 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.
• Organize workload of laboratory and provide management with feedback of overall laboratory performance.
• 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. This includes the documentation of aberrant events and mistakes that occur through the documentation process.
• 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.
• Work with minimal supervision, re-prioritizing work schedules quickly.
• Be proficient in performing testing that are in alignment with USP standards.
• 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.
• 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.

Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping.

Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb.

Visual Acuity: Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.

Environmental/Atmospheric Conditions: 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 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.

Knowledge: 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. 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?

Experience: 0-1 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. Demonstrated interpersonal skills are vital. Must be able to work well independently and make quick decisions under pressure.

Machines, Tools, Equipment and Work Aids: Computer & related programs, laboratory glassware, sampling equipment, chemical reagents, Federal Register, and standard office equipment.

License(s)/Certification(s) Required: None identified