Jobs
>
Bothell

    Deviation Investigator - Bothell, United States - LanceSoft

    LanceSoft
    LanceSoft Bothell, United States

    3 weeks ago

    Default job background
    Description

    Job Title:
    Deviation InvestigatorLocation: Bothell, WA 98021Duration: 12 Months

    Job Description:

    The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Client located in Bothell, WA.The Deviation Investigator on the MSAT team is an individual contributor role responsible for investigating No Impact, Minor, Major, and Critical deviations to determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations.

    This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the manufacturing and laboratory investigations and determine the associated corrective action to prevent the deviation from reoccurring.

    This person will be a key player in the Client MSAT team and a champion for quality priority principles and compliance within the Client organization.

    Minimum of Bachelors degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.5+ years of relevant cGMP experience.

    Experience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferred.
    Minimum of 2 years working within quality systems managing deviation and CAPA records.
    Experience authoring deviation and CAPA recordsDemonstrated proficiency in selection of team and effectively managing personnel issues is highly desired. Proven ability to demonstrate attention to detail, personal and team accountability where it is critical to success.


    Knowledge, Skills, and Abilities:
    Expertise in GMP compliance and FDA/EMA regulations.
    Demonstrate excellence in written and verbal communication.
    Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
    Innovative, proactive, and resourceful; committed to quality and continuous improvement.
    Ability to anticipate and mitigate challenges.#J-18808-Ljbffr
  • Integrated Resources

    Deviation Investigator

    3 weeks ago

    Integrated Resources Bothell, United States

    Job Title: Deviation Investigator · Location: Bothell, WA · Job Duration: 12 Months · Pay Rate: $63.86/Hr. on W2 · Job Description: · The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records th ...

  • Aequor

    Deviation Investigator

    2 days ago

    Aequor Bothell, United States

    Position: Deviation Investigator · Location: Bothell WA 98021 · Duration: 12+ months (possibility of extension for the right candidate depending on performance) · Pay rate: $63.86/ hour on W2 · A minimum of a Bachelor's degree in a relevant Science or Engineering discipline and/ ...

  • LanceSoft, Inc.

    Deviation Investigator

    2 weeks ago

    LanceSoft, Inc. Bothell, United States

    Job Title: Deviation Investigator · Location: Bothell, WA 98021 · Duration: 12 Months · Job Description: · The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record ...

  • Axelon Services Corporation

    Deviation Investigator

    3 weeks ago

    Axelon Services Corporation Bothell, United States

    Pay range: $60 - $65/hr on W2 · Job Description: The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (Jump) l ...

  • Axelon

    Deviation Investigator

    3 weeks ago

    Axelon Bothell, United States

    Pay range: $60 - $65/hr on W2 · Job Description: The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (Jump) ...

  • Katalyst Healthcares & Life Sciences

    Deviation Investigator

    2 weeks ago

    Katalyst Healthcares & Life Sciences Bothell, WA, United States

    Responsibilities: Expertise in GMP compliance and FDA/EMA regulations. Demonstrate excellence in written and verbal communication. Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships. Innovative, proactive, and resourc ...

  • Axelon Services Corporation

    Deviation Investigator

    2 minutes ago

    Axelon Services Corporation Bothell, United States

    Pay range: $60 - $65/hr · Job Description: The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality record management system at the Juno Manufacturing Plant (Jump) loca ...

  • TSR Consulting Services, Inc.

    Deviation Investigator

    4 days ago

    TSR Consulting Services, Inc. Bothell, United States

    TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. · Our client, a leading pharmaceutical company is hiring a Deviation Investigator on a contract basis. Please only local candidates to Bothell WA. Relevant cGMP experience is a must. · Work ...

  • LanceSoft

    Deviation Investigator

    3 weeks ago

    LanceSoft Bothell, United States

    Job Title: Deviation Investigator · Location: Bothell, WA 98021 · Duration: 12 Months · Job Description: · The MSAT (Manufacturing Sciences and Technology) team is responsible for overseeing and supporting the management of deviation records through the electronic quality rec ...

  • Net2Source Inc.

    Quality Investigator

    2 weeks ago

    Net2Source Inc. Bothell, United States

    Position: Deviation Investigator · Location: Bothell, WA · Duration: 12 months+ Months (Extendable) Projected for 12 months and beyond depending on the business need. · This Position is onsite · Pay Rate: $63/hr on W2 Paid weekly (Without Benefits included in the pay you will ha ...

  • Omni Inclusive

    Quality Assurance Operations

    2 weeks ago

    Omni Inclusive Bothell, United States

    Job Title: Senior Specialist, Quality Assurance · Location: Bothell, WA** 100% Onsite · *TOP SKILLS* · - 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system. · - Demonstrated ability to w ...

  • SSi People

    Quality Assurance Specialist

    2 days ago

    SSi People Bothell, United States

    Quality Assurance Specialist · Location: Bothell, WA · Major duties and responsibilities: · Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and metrics. · Investigation & CAPA Review Board ...

  • Axelon Services Corporation

    Senior Quality Assurance Specialist

    2 days ago

    Axelon Services Corporation Bothell, United States

    This is a W2 contract role. No C2C/corp to corp · Pay Range : $80 to $88 per hour on W2 · Job Description: · Quality Systems support within Quality Operations. Ensure that *** Co. products manufactured at external contract manufacturers are manufactured, tested and released acco ...

  • TSR Consulting Services, Inc.

    Pharmaceutical Quality Support Specialist

    2 days ago

    TSR Consulting Services, Inc. Bothell, United States

    TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. · Our client, a leading pharmaceutical company is hiring a Pharmaceutical Quality Support Specialist on a contract basis. Please only local candidates to Bothell WA only. A minimum of 3 yea ...

  • Eclaro

    Quality Assurance Specialist

    2 days ago

    Eclaro Bothell, United States

    JOB TITLE: Quality Assurance Specialist · Location: Bothell, WA (100% onsite ) · Duration: 6 months initial (potential extension/potential right to hire) · Job Description: Quality Systems support within Quality Operations. Ensure that *** Co. products manufactured at external co ...

  • Katalyst Healthcares & Life Sciences

    Investigator I

    2 weeks ago

    Katalyst Healthcares & Life Sciences Bothell, WA, United States

    committed to quality and continuous improvement. Immediately upon assignment of an investigation, partners with their investigation team (QA Reviewer/ Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, requi ...

  • Axelon Services Corporation

    Senior Quality Assurance Specialist

    2 minutes ago

    Axelon Services Corporation Bothell, United States

    Pay Range : $80 to $88 per hour on *** · Job Description: · Quality Systems support within Quality Operations. Ensure that *** Co. products manufactured at external contract manufacturers are manufactured, tested and released according to established Client specifications and ...

  • Aequor

    QA Shop Floor Specialist

    3 weeks ago

    Aequor Bothell, United States

    Position: QA Shop Floor Specialist · Location: Bothell WA 98021 · Duration: 6 months (possibility of extension for the right candidate depending on performance) · Pay rate: $42.41/ hour on W2 · **Schedule- 9:00 pm - 7:30 am, Sun-Wed** · **Top Skills: · 3-5 years of GMP work expe ...

  • Pyramid Consulting, Inc

    QA Shop Floor Specialist

    2 weeks ago

    Pyramid Consulting, Inc Bothell, United States

    Immediate need for a talented QA Shop Floor Specialist. This is a 06+ Months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: $35 - $42/h ...

  • Axelon Services Corporation

    Quality Assurance Specialist

    1 week ago

    Axelon Services Corporation Bothell, United States

    This is W2 contract NO c2c/Corp to corp · Pay range: $40 to $44 per hour on W2 · Job Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degr ...