Qureos Mentor

Nice-Pak Products

<div>Summary:
Essential Duties and Responsibilities:<ul><li>
Answer Technical specification requests, questionnaires and forms. Review QA Master Data and provide weekly report. All other projects as directed such a CARB. Write and complete response for UL or BV unacceptable reports quality related issues within10 business days or within allotted timeframe.</li><li>
Update customer specifications through web portals as requested by sales.</li><li>
Coordinates the retrieval of quality information (surveys, etc&hellip;) for the customer. Communicates and coordinates changes requested by customer (component changes or special instructions).</li><li>
Support and conduct Target Inspection process at Distribution Center (DC).</li><li>
Review records or inspect retains on request to support investigations.</li><li>
Projects for QA Director as assigned</li></ul>
Supervisory Responsibilities:
None
Competencies:<ul><li>
Must have working knowledge of computer usage including Microsoft Word, Microsoft Excel, Microsoft Access and SAP, and other work processing, database, or spreadsheet programs</li><li>
Works well with computers (ability to create spreadsheets, databases, etc&hellip;), Technical writing skills. Ability to analyze data &amp; track trends. Ability to analyze problems utilizing basic tools (pareto charts, root cause analysis, gap analysis, etc&hellip;)</li><li>
Requires excellent writing and organizational skills</li></ul>
Certificates, Licenses, Registrations:
None
Travel:
Limited
Work Environment:
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Physical Demands:
Standing and walking &ndash; 30% of time on job; sitting &ndash; 70% of time on job; climbing stairs and ladders, repeated motion of hands (typing) &ndash; 30% of time on job; communicate (talking and listening) &ndash; 75% of time on job; identifying colors &ndash; 20% of time on job, ability to see. Ability to bend, stoop, and kneel and the ability to visually track moving objects.
Education Requirements:
Minimum of Associates Degree or college level course work which includes: 1 year of general chemistry, Basic English
(English/Composition 101, etc&hellip;). Technical Writing course work preferred. Some computer course work preferred.
Previous experience can be substituted for education.
Experience Requirements:
A minimum of 5 years of experience in a regulated industry is required. A background in chemistry preferred.
Personal computer proficiency required.</div>

SPECIALIST QUALITY MICRO

<div>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:
<ul><li>Finished Product Testing</li><li>
Antimicrobial Effectiveness Testing</li><li>
Environmental Monitoring
</li><li>Test Method Validation</li></ul>
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:
<ul><li>Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts.</li><li>
Presence at work on time when scheduled is a mandatory function.
</li><li>Compliance with all company safety rules, procedures, and guidelines is mandatory.</li><li>
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.</li><li>
Organize workload of laboratory and provide management with feedback of overall laboratory performance.</li><li>
Coordinate information flow within the laboratory and to internal customers.
</li><li>Access, input, and retrieve information from the QC computer systems.</li><li>
Disposition of raw materials, process samples and finished products for use or sale.</li><li>
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.
</li><li>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.
</li><li>Work with minimal supervision, re-prioritizing work schedules quickly.</li><li>
Be proficient in performing testing that are in alignment with USP standards.
</li><li>Become familiar and assist with OOS/OOT and Customer complaint investigations.</li><li>
Become familiar and assist with Method Development Protocols and conduct requisite testing.
</li><li>Become familiar and assist with SOP creation, review, and revision activities.</li><li>
Become familiar and assist with the ordering of supplies, services, reagents, organisms, and other consumables in the lab</li><li>
Become familiar and assist with instrument maintenance, calibration, and troubleshooting.</li><li>
Must be able to perform any routine task in the laboratory in an efficient manner.
</li><li>Participate in meetings as required.</li><li>
Complete training assignments as required.</li><li>
All other duties as assigned.</li></ul>
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 &amp; related programs, laboratory glassware, sampling equipment, chemical reagents, Federal Register, and standard office equipment.
License(s)/Certification(s) Required: None identified</div>

SPECIALIST QUALITY

<div>POSITION SUMMARY: Perform set up, routine maintenance, adjustments, troubleshooting and repairs on liquid fill production line equipment (fillers cappers and labelers), pneumatic, hydraulic and electrical machines.
RESPONSIBILITIES OF THE POSITION:
Essentials Functions
1. Behavior: Team player qualities of cooperation and coordination, professional interaction with all business contacts all day, every day.<ul><li>
Attendance: Exceptional attendance is a mandatory requirement. Eight hour day including extra hours daily; Saturdays, Sundays, and Holidays.</li><li>
Safety: Comply with all requirements of the safety program, including: hazard recognition, housekeeping, accident and near miss reporting, proper use of all safety equipment and procedures, adherence to all Safety Rules and your reporting of safety issues is mandatory.</li></ul>
4. Change parts; set up and adjust lines for various products; monitor line as time permits or as directed.
5. Diagnose machine malfunctions and operating difficulties; make the necessary repairs and adjustments.
6. Wash out fillers between products.
7. Make the necessary adjustments for fillers, cappers, and labelers.
8. Inform supervisors of parts and equipment used and needed for replacement.
9. Ensure proper torque fills and overall quality by initiating contact with quality control.
10. Perform routine daily maintenance such as greasing, oiling, changing belts; perform established periodic preventative maintenance.
11. Process and store hazardous, flammable material such as nail polish remover, etc. in accordance with established local, state and federal guidelines.<ul><li>
Be proficient in the tasks as outlined in the SKILL LEVEL ESSENTIAL FUNCTIONS Table.</li></ul>
Marginal Functions
13. Assist lead operators to keep production running, which may entail putting bottles on line, packing and assisting with labels.
Physical Activities: Walking, reaching, grasping, talking, hearing, standing, climbing, stooping, feeling, crawling.
Physical Demands: Function 1 requires lifting small parts weighing 25 to 60 lbs by hand, a variety of physical movement necessary to repair and install machinery.
Visual Acuity: Clarity of vision at 20 inches or less with the ability to judge distance and space relationships. Ability to adjust eye to bring objects into sharp focus. Continuous mental and visual attention.
Environmental/Atmospheric Conditions: Worker is protected from weather conditions but not from temperature changes which may be sufficiently high or low to cause bodily discomfort. Worker exposed to sufficient noise level requiring hearing protection. Worker exposed to a variety of physical conditions such as moving mechanical parts, electrical current, and high heat.
Knowledge: Requires the ability to read, write, add, subtract, multiply and divide; work from drawings, schedules, and make some interpretations; equivalent to two years of trade school.
Experience: Requires a minimum of one year of similar maintenance/mechanical experience or two year trade school/Associate Degree in a related mechanical field.
Machines, Tools, Equipment and Work Aids: Filler, capper, labeler, bander, tape machine, unscrambler, drill, grinder, and a variety of hand tools.
License(s)/Certification(s) Required: None identified.
Job Type: Full-time</div>

MAINTENANCE MECHANIC 3rd shift

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SPECIALIST QUALITY MICRO

SPECIALIST QUALITY

MAINTENANCE MECHANIC 3rd shift