Jobs
>
Irvine

    Quality Regional/Quality Document Control - Irvine, United States - ABO Plasma

    ABO Plasma
    ABO Plasma Irvine, United States

    3 weeks ago

    Default job background
    Description

    Job Description

    Job Description

    Classification: Salaried/Exempt
    Reports to: Director of Quality Assurance & Regulatory Affairs

    PURPOSE


    Assist the Director of QA/RA in achieving center quality goals while ensuring centers adhere to Standard Operating Procedures, Current Good Manufacturing Principles, and Company Policies.

    General Requirements—Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, Company Policies, Consignee Requirements, and Applicable Regulations.

    ESSENTIAL RESPONSIBILITIES & DUTIES

    • Responsible for reviewing and approving critical error reports (Deviations, issues, lookbacks, post donation information reports, and BPDRs). Consistently track each error report to completion. Responsible for final submission of all BPDRs and lookbacks.
    • Perform document control functions to assist with writing, revising, and implementation of policies and procedures.
    • Perform internal center audits of ABO Plasma centers. These audits will be on-site with support of off-site record reviews and requests.
    • Supervising the center Quality Managers and the production process to make sure that all products meet consistent standards.


    HAS AUTHORITY TO:

    • Instruct any and all facilities to stop production - if the strength, purity, identity, or quality of the unit is in question or if donor safety has been compromised.
    • Instruct any and all facilities to stop the release of shipments – if the release of a shipment does not meet any of the required standards as set forth in the SOP.


    ASSIST THE DIRECTOR OF QA/RA TO PERFORM THE FOLLOWING:

    • Assist in development and utilization of Quality management team (Center Quality Manager, Trainer, QA Coordinator).
    • Review deviations, issues, and assist facilities to resolve compliance issues.
    • Review post donation information reports to ensure proper actions taken by center.
    • Review BPDRs for accuracy and ensure their timely submission.
    • Review Lookback Reports for accuracy and ensure their timely submission.
    • Must have working knowledge and follow Consignee's specifications regarding the collection of plasma and shipment of units.
    • Must have knowledge of and ensure compliance the required Federal, State and local regulations as they pertain to each facility.
    • Must maintain an understanding of all functions of center activities.
    • Document Control – Responsible in maintaining company policies, procedures, and documents.
    • Travel to ABO Plasma centers for the purpose of Auditing, Training, or departmental support.

    OTHER RESPONSIBILITIES

    • Accept other assignments as delegated by Director of QA/RA.
    • Must be able to track error outcomes to ensure strong regulatory compliance.
    • Report weekly/monthly to Director of QA/RA.
    • Report Emergency Situations Immediately.
    • Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and otherwise posted or communicated.
    • Maintain consistent communication with QA managerial team and/or Director of QA/RA to provide all necessary information regarding the center or requested information from corporate office.
    • Maintain constant interaction with Center Quality Managers and Training Manager to ensure the center is quality oriented and prepared to successfully pass all audits.
    • Must be able to balance competing priorities and adherence to quality standards.
    • Any other duties as assigned.

    REQUIREMENTS

    • High School Diploma or Equivalent. Associate's degree preferred.
    • One-year experience in a donor center with similar Quality Assurance or medical field experience or equivalent combination or education, training, and experience preferred.
    • Organizational and communication skills required.
    • Organized and have Computer skills including proficient in Microsoft Office.
    • Demonstrate spreadsheet and database computer skills.
    • Must be able to work independently and multi-task effectively.
    • May require travel up to 60%
    • Excellent customer service skills
    • Excellent team player and ability to work with others
    • Strong leadership abilities

    PHYSICAL DEMANDS

    Performing the responsibilities of the job requires close vision, distant vision, peripheral vision, depth perception, and ability to adjust visual focus. Ability to communicate effectively, stand or sit, reach with arms and hands, use hands or fingers to handle or feel. Ability to move physical records for review, up to 10 pounds, read and review documents for up to eight (8) hours at a time, and type at a computer for up to 2 - 3 hours at a time.

    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. May be exposed to bloodborne pathogens and other conditions common to a donor center. Work in a walk-in freezer for short intervals of time (-20C or colder).

  • Biomerica, Inc.

    Document Control Associate

    3 weeks ago

    Biomerica, Inc. Irvine, United States

    **Document Control Associate (IVD Medical Device, Immunoassay)** · **Biomerica Irvine, CA USA** · At Biomerica, we improve lives by developing, manufacturing and marketing products designed to enhance the health and well-being of people, while reducing healthcare costs. We are a ...

  • Masimo

    Document Control Specialist

    6 days ago

    Masimo Irvine, United States

    **Job Summary** · The Document Control Specialist/ Document Control Specialist II / Sr. Document Control Specialist is responsible for administering and maintaining the company's controlled documents, records, and the document control system in accordance with company requirement ...

  • Western Digital

    Specialist 3, Document Control

    1 week ago

    Western Digital Irvine, United States

    **Company Description** · At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible. · At our core, Western Digital is a company of problem solvers. People achieve extraordinary things ...

  • Infinite Electronics International, Inc.

    Document Control Specialist Level Ii

    2 weeks ago

    Infinite Electronics International, Inc. Irvine, United States

    **Position Description** · Infinite Electronics' brands include Pasternack, Fairview Microwave, L-Com Global Connectivity, MilesTek, Aiconics, Polyphaser, Transtector, Integra Optics and Show Me Cables, and NavePoint. · This is the opportunity for an ambitious Document Control Sp ...

  • ABO Plasma

    Quality Regional/quality Document Control

    3 weeks ago

    ABO Plasma Irvine, United States

    **Classification: Salaried/Exempt** · **Reports to: Director of Quality Assurance & Regulatory Affairs** · **PURPOSE** · Assist the Director of QA/RA in achieving center quality goals while ensuring centers adhere to Standard Operating Procedures, Current Good Manufacturing Princ ...

  • Cordoba Corporation

    Document Controls Specialist

    5 days ago

    Cordoba Corporation Santa Ana, United States

    Overview: · Cordoba Corporation is a leading civil engineering firm based in California specializing in education and facilities, transportation, water and energy sectors. We are seeking a Document Controls Specialist to assist the Information Systems Manager in partnering with s ...

  • SNC Engineering Inc

    Document Controller

    2 weeks ago

    SNC Engineering Inc Fullerton, United States

    **Company**: SNC Engineering · SNC Engineering is a steel detailing company specializing in the production of shop drawings for steel fabricators and erectors. We play a crucial role in facilitating the fabrication and installation processes for various projects. · We are experie ...

  • Orthofix

    Document Control Specialist

    3 weeks ago

    Orthofix Irvine, United States

    Why Orthofix? · We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, w ...

  • Pacifico Power

    Document Controller

    1 day ago

    Pacifico Power San Juan Capistrano, United States

    **About us**: · Pacifico Power is a startup focused on developing, constructing, owning, and managing behind-the-meter commercial energy projects. The company will expand into storage, micro-grids, and community-based energy distribution as the regulations continue to loosen and ...

  • Nikkiso Cryogenic Industries

    Document Control Coordinator Iii

    2 weeks ago

    Nikkiso Cryogenic Industries Santa Ana, United States

    **Nikkiso Clean Energy & Industrial Gases** is a leading provider of cryogenic pumps, heat exchangers, process systems, services, and solutions for the LNG and industrial gases industry. We are a subsidiary of Nikkiso Company Ltd, a leading industrial manufacturer headquartered i ...

  • TSG Enterprises

    Document Controller

    1 week ago

    TSG Enterprises Pomona, United States

    **Document Controller / Program Coordinator** · **Job description** · The Solis Group is seeking a highly motivated Document Control Specialist/ Program Coordinator for a transit construction program in Pomona, CA. This individual will be responsible for the intake and management ...

  • All Care To You, LLC

    Document Control Clerk

    3 weeks ago

    All Care To You, LLC Orange, United States

    **About Us** · All Care To You is a Management Service Organization providing our clients with healthcare administrative support. We provide services to Independent Physician Associations, TPAs, and Fiscal Intermediary clients. ACTY is a modern growing company which encourages di ...

  • Regenerative Medical Group

    Document Control Specialist

    2 days ago

    Regenerative Medical Group Orange, United States

    Regenerative Medical Group is seeking a well-experienced professional to manage the day-to-day documentation responsibility for a thriving and innovative medical practice in Orange. This role includes document management, coordination, and communication between various department ...

  • HNTB Corporation

    Document Control Specialist Iii

    1 week ago

    HNTB Corporation Santa Ana, United States

    **What We're Looking For** · At HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the country ...

  • Kelly

    Document Control Specialist

    3 weeks ago

    Kelly Irvine, United States

    Kelly Services voted America's Best Professional Recruiting Firm by Forbes in 2023 is proud to announce we are now partnering with Johnson & Johnson located in Irvine, CA. · Johnson & Johnson is immediately hiring multiple Quality Assurance Associates specializing in Document Con ...

  • Masimo

    Document Control Specialist

    4 days ago

    Masimo Irvine, United States

    Job Description · Job Summary · The Document Control Specialist/ Document Control Specialist II / Sr. Document Control Specialist is responsible for administering and maintaining the company's controlled documents, records, and the document control system in accordance with comp ...

  • Cordis

    Document Control Specialist

    6 days ago

    Cordis Irvine, California, United States Permanent

    Overview: · MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize health ...

  • Virgin Galactic

    Document Control Specialist

    2 weeks ago

    Virgin Galactic Tustin, United States

    The Document Control Specialist will be responsible for the release of Engineering deliverables, such as engineering drawings, production work instructions, engineering specifications, documents, and company processes and procedures. They will provide support on program configura ...

  • tapwage

    Document Control Specialist

    1 day ago

    tapwage Irvine, United States Full time

    Overview · MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthc ...

  • Winchester Electronics

    Document Control

    2 weeks ago

    Winchester Electronics Garden Grove, United States

    As our Document Control for El-Com Systems, a division of Winchester Interconnect, located in Garden Grove, you will be responsible for data input and change management of all Master Engineering files for El-Com. Take direction from the Manufacture Engineer who has responsibility ...