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    Quality Technician III - Asheville, United States - Jabil

    Jabil
    Jabil Asheville, United States

    2 weeks ago

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    Description
    At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER.

    We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions.

    With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions.

    Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.


    Position Summary:


    This position controls and issues all related Quality documentation, Maintains documents and records within GMP regulation guidelines and is responsible for the Records Retention and Disposition Program and supports the Quality Systems Organization with Document Control tasks and administrative tasks to support Compliance.

    This position also observes company rules, regulations, and procedures, such as safety, housekeeping, attendance to educational activities and follows SOP's and work instructions.

    This position shall assure timely identification, recording and distribution of all documentation for ease of manufacturing.

    Safety, cGMP and Operational Excellence

    Complies with all PPE requirements and coaches and supports all employees' adherence.


    Helps to ensure that documentation practices comply with cGMP requirements – i.e., properly develops training materials & completes training records and eliminates sticky notes and other uncontrolled documentation where found.


    Learns to apply and support 5S, Lean, Visual Factory and other OpEx principles as they pertain to Quality Control/Quality Assurance.


    Essential Functions and Responsibilities:
    Responsible to support the company's-controlled documents process accordance with customer and company requirements.

    Establish/maintain procedures for maintaining documents and change control of documents requiring a physical distribution through the site.

    Compile and maintain control records and related files.


    Supports the Quality Engineering team with the release and update of customer's documents in the Quality Documentation System as part of activities such as Change Controls and/or Complaints investigations.


    Determine and enforce - through functional groups - document control requirements in order for the company to meet internal and external needs.

    Trains document initiators and approvers in the requirements and mechanics of the Quality Documentation System per the Document and Data Control Procedure

    Responsible to support the company's-controlled documents process in accordance with customer and company requirements.

    Establish/maintain procedures for maintaining documents and change control of documents requiring a physical distribution through the site.

    Compile and maintain control records and related files.


    Supports the Quality Engineering team with the release and update of customer's documents in the Quality Documentation System as part of activities such as Change Controls and/or Complaints investigations.


    Determine and enforce - through functional groups - document control requirements in order for the company to meet internal and external needs.


    Trains document initiators and approvers in the requirements and mechanics of the Quality Documentation System per the Document and Data Control Procedure.


    Administers the Quality Record and Retains Rooms, including activities such as logging records being stored, coordinating its transference to the External Storage or its retrieval, when needed.

    In addition to administering and coordinating the dispositions of Quality Records upon retention shelf life period.

    May support the Quality System Manager, in the administrative process of receiving and handling customer complaints, and associated tasks.

    Gathers and compiles Quality Department Metrics data and updates related files periodically.

    Acts as main liaison with External Storage Supplier to ensure adequate records retention and retrieval process.

    Observes all company rules, regulations, and procedures such as safety and housekeeping (6's).

    Complies with Good Manufacturing Practices

    Responsible that his/her payroll clock punches are registered before entering or leaving, following and accepting company payroll policies

    Responsible of performing as per Job Description's SOP's and work instructions.

    Attends all requested training or company meetings.

    May participate in internal committees as Safety, improvement events, internal audits etc. as required


    Communication:


    Keeps Quality Engineer and Quality Assurance Manager updated on Quality issues and status, including NCMR, CAPA, Internal Audits and QMS documentation needs.


    Provides guidance to Document Initiators and creates an environment where input and feedback are encouraged and acted upon as appropriate.


    Coordinates with the Quality Engineer and Operations functions to provide effective support in Document Release, NCMR / CC / CAPA Investigations, Documentation Updates, and other activities as needed.


    Knowledge and Skills:

    Proofreading/Grammar:
    Writes and proofreads written material with a high level of accuracy.

    Ability to manage a variety of projects as assigned

    Presentations development skills

    Computer Literate:
    Windows, Microsoft Word, PowerPoint, Excel, Access,

    Adaptable:
    Ability to perform a variety of tasks, often changing assignments on short notice.

    Initiative:
    Self-starter, working well without close supervision.

    Strongly organized.

    Ability to handle multiple priorities

    ISO 13485 and QSR FDA standards knowledge

    Basic SAP system knowledge

    Excellent communication skills

    Ability to work under minimum supervision

    Team player


    Physical Requirements:
    Work in front of computer screen for extended periods.

    Able to work under pressure

    Handle multiple priorities from different persons


    BE AWARE OF FRAUD:

    When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a e-mail address.

    Jabil does not request payments for interviews or at any other point during the hiring process.

    Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver's license number or passport information over the phone or via e-mail.

    If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline ), the Federal Trade Commission identity theft hotline ) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.


    Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

    Accessibility Accommodation


    If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access site as a result of your disability.

    You can request a reasonable accommodation by sending an e-mail to or calling with the nature of your request and contact information.

    Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.
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