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ELITE One Source Nutritional Services Quality Assurance Technician-Operations in Missoula, Montana

Position Overview

The QA Technician – Operations is responsible for maintaining systems that are associated with Operation functions. This includes maintaining the Nonconforming and Material Evaluation processes and updating various databases, reviewing batch records prior to release to Operations, review of cyclic overdue materials, and control of completed associated GMP data records. They will be responsible for several aspects of the compliance system as it relates to Quality Assurance.

Essential Functions

Nonconforming Materials:

  • Processes all submitted NCRs for the MRB.

  • Support QA MRB daily meetings, taking notes on decisions and issuing the tasking from the MRB meetings.

  • Distribute copies of NCRs with MRB decisions and or assigned tasks.

  • Track open NCRs for response from other departments individuals.

  • Input all NCR data into data base and update data base as NCRs are processed.

  • Maintain the Noncon inventory quarantine by moving items into the cage which are in nonconforming status and scrap items as directed by MRB.

  • Upon request, generate rework order record and close out rework order when it is completed by production.

  • Assist Purchasing with processing freight claims.

Batch Records:

  • Batch Record review and sign off on new production batch records before the records are released to production.

  • Close out and final review of production batch records.

Document Control:

  • Maintain Data Record systems. This includes but is not limited to:

  • Non-conforming material.

  • Material Evaluation records.

Miscellaneous:

  • Work with the Quality Assurance Manager to establish area goals.

  • Cross train with QA Technician – Documentation Control and QA Specialist on all job functions and act as the delegate in their absence.

  • Identify process improvement opportunities whether through procedure/process changes or technology advancement and review with the Quality Administration Manager.

  • Train and mentor users of the systems to assure compliance and maintain the integrity of the systems.

Qualifications

Education/Experience:

  • Advanced education (i.e. college, technical school) preferred.

  • Two years recent computer experience (working with Microsoft Office and Access programs).

  • Technical writing experience.

Skills:

  • PC and software skills:

  • ERP system experience, preferably in a manufacturing environment.

  • Microsoft Office Suite. Emphasis on Excel.

  • Good interpersonal skills and a team player.

  • Strong oral and written communications inclusive of negotiation skills.

  • Attention to detail and accuracy in work flow and organizational and analytical skills.

  • Ability to manage time effectively and meet deadlines and requirements accordingly.

  • Ability to perform in a fast pace environment with minimal direct supervision.

  • Strong math skills.

  • Strong file maintenance & cataloging skills.

Physical Requirements

Working Conditions in the Office Setting:

  • Primary functions require sufficient physical ability to work in an office setting and operate office equipment.

  • Business casual attire.

Working Conditions on the Production Floor:

  • Must be able to work in a fast-paced light manufacturing environment.

  • PPE requirements: safety glasses, respiratory protection, company supplied lab coats, and gloves

  • GMP gowning requirements: Hair net, beard guard (if applicable), shoe covers, and sweatbands as required

Physical Demands:

  • Ability to stand, walk, stoop, kneel, crouch, and manipulate (lift, carry, move) light to medium weights of up to 55 pounds.

  • Sitting for prolonged periods of time.

Cover-All Clause

The preceding essential functions, qualifications, and physical requirements have been provided as examples of the types of work performed by employees assigned to this job classification. ELITE ONE SOURCE® Nutritional Services, Inc reserves the right to add, modify, change, or rescind the work assignments of any position and to make reasonable accommodations so that qualified employees can perform the essential functions of the job. Additionally, employees of ELITE agree to accept and complete additional projects as assigned by a member of management.

Regulatory Compliance

All Employees agree to comply with a strict adherence to Company and OSHA safety requirements, Standard Operating Procedures (SOP’s), Good Manufacturing Practices (GMP) Compliance, and Food and Drug Administration (FDA) regulatory standards.

Commitment to Safety

At ELITE we consider the safety, health, and security of our employees, the integrity of our assets, the protection of the environment, and the quality of our service to be integral to the efficient management of our business. We believe that all injuries, illnesses, and incidents arising from things we do in the course of our business are preventable and we are committed to preventing harm to anyone as a result of our operations. We put SAFETY F1RST in everything we do. We each have a responsibility for our own safety and for the safety of others. Maintaining high standards of health and safety, ensuring the safe operations of our facilities, vehicles, and other assets is good for our employees, our customer, our business, and the communities in which we operate.

We are committed to continual and sustainable improvements in our health and safety performance and will ensure, our employees and others who may be affected by our operations, are not exposed to risks to ether their health or safety. The ultimate responsibility for health and safety and environmental compliance within ELITE lies with the Senior Management team. They have the overall responsibility for the health and safety of all our employees and for ensuring that the risks and impacts from our activities are understood and mitigated. However, everyone at ELITE must understand the part they play to help contain health and safety risks and that this is part of our everyday work. It is the responsibility of every individual working within the business to make themselves aware of possible health and safety risks and to take reasonable measures to reduce this risk in their working environment.

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