• Quality System Specialist II Temp-Hire

    Location US-CA-Richmond
    Requisition ID
    2018-7279
    # of Openings
    1
    Category
    Engineering
  • Overview

    Responsibilities

    This position will provide both direct support for key Document Control systems associated with our QMS as well as assist the QA Management team with administrative activities (e.g. process payroll, requisitions, manage calendars, schedule meetings and create agendas, etc.).  Responsibilities include: control and maintain the electronic Change Order Process, review and approve DCOs and ERs; develop and/or revise SOPs and WIs; organize, support and/or serve as auditor for the LSG Internal Audit Program; perform activities related to tracking and review of nonconformances and deviations; provide support to our internal customers and provide direct support to the Quality Assurance (QA) Department. Hire will be based out of Bio-Rad’s 3110 Regatta (Richmond) Facility and will be responsible for the following:

    • Reviews and compiles batch records (i.e. DHRs) for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements.  Identifies and documents deviations as appropriate.
    • Maintain and archive controlled documentation and completed quality records. Provide access to controlled documents as per procedure(s).
    • Provide support during external audits or inspections
    • Supports activities related to the Change Control Process at the site.
    • Works with operations personnel to investigate, document and manage deviations, non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate with a willingness to improve quality procedures and methods.
    • Assists with performing internal audits and investigations.
    • Analyzes and prepares data for reports and recommendations for management reviews.
    • Assists with Quality System projects as necessary.
    • Supports databases and systems used for tracking various QMS activities.

     

    Qualifications

    • A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
    • Requires 3+ years related experience.
    • Experience working in both an FDA and ISO 13485: 2016 is desired.
    • SAP experience a plus
    • Proficient in Microsoft Word, Excel, PowerPoint and project planning tools.
    • Relevant experience working in manufacturing/operations is required
    • The ability to effectively communicate issues to both technical and non-technical audiences.
    • Strong planning, organization, problem solving and time management skills required.
    • Must have excellent analytical and communication (written and verbal) skills as well as highly effective interpersonal skills;
    • Able to work independently and make informed decisions regarding daily operations without direct intervention from a supervisor.
    • Able to manage multiple and varied tasks with a high level of specificity and also prioritize workload and report on progress.
    • Ability to work in a project/team environment through utilization of solid decision-making and conflict resolution skills.
    • .Strong customer focus and ability to work effectively with cross-functional groups.

     

     

    About Bio-Rad:

     

    Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

     

    Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

     

    EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/AgeTo all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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