Deviation Investigator

3 weeks ago

Bothell WA, United States Katalyst Healthcares & Life Sciences Full time

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 resourceful; committed to quality and continuous improvement. Ability to anticipate and mitigate challenges. Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date. 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, required data, and timing for completion. Continues to partner with investigation team throughout the investigation process to ensure agreement / alignment on root cause and CAPA. When CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements. Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closure. Requirements: Minimum of Bachelor's 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 records Demonstrated 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. Owns and investigates department-specific trend deviations. Leads investigation team to perform deep-dive analysis of department-specific trends, including to. Assess trend details to ensure accuracy and alignment across the team. Facilitate in-depth root cause analysis to determine additional process and system failure modes. Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend. Determine if previous identified CAPA are sufficient to reduce the trend by defined targets. Leads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviations. Applies HOP (Human and Organizational Performance) principles to investigations. Uses both soft-skills and technical skills to drive the deviation and CAPA processes: Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers. Seeks to understand, demonstrates humility, and shows curiosity for learning. Completes deviations that are thorough, accurate, and complete. Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase. Understands appropriate assignment of classifications and requirements for each. Understands the importance and impact of lot association within deviations and the relation to product disposition. Captures the necessary data to support containment activities and impact assessment. Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record. Performs investigations and root cause analyses that are commensurate to the event being investigated. Understands multiple RCA tools and when, where, and how to apply them. Utilizes good technical writing skills. Contacts vendor as needed to complete investigations in a timely manner. May participate on deviation governance teams, projects, and other initiatives.

  • Deviation Investigator

    1 week ago

    Bothell, United States TSR Consulting Services, Inc. Full time

    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 Location: Bothell WAPay: $62-63W2 Required Skills: Responsible for overseeing and...

  • Deviation Investigator

    1 week ago

    Bothell, United States TSR Consulting Services, Inc. Full time

    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 Location: Bothell WAPay: $62-63W2 Required Skills: Responsible for overseeing and...

  • Deviation Investigator

    1 week ago

    Bothell, United States TSR Consulting Services, Inc. Full time

    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 Location: Bothell WAPay: $62-63W2 Required Skills: Responsible for overseeing and...

  • Deviation Investigator

    7 days ago

    Bothell, United States Aequor Full time

    Position: Deviation Investigator 57888-1Location: Bothell WA 98021Duration: 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/or equivalent combination of work experience is required.• 5+ years of relevant...

  • Deviation Investigator

    7 days ago

    Bothell, United States Aequor Full time

    Position: Deviation Investigator 57888-1Location: Bothell WA 98021Duration: 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/or equivalent combination of work experience is required.• 5+ years of relevant...

  • Deviation Investigator

    1 month ago

    Bothell, United States LanceSoft, Inc. Full time

    Job Title: Deviation InvestigatorLocation: Bothell, WA 98021Duration: 12 MonthsJob 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...

  • Deviation Investigator

    1 month ago

    Bothell, United States LanceSoft, Inc. Full time

    Job Title: Deviation InvestigatorLocation: Bothell, WA 98021Duration: 12 MonthsJob 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...

  • Deviation Investigator

    1 month ago

    Bothell, United States LanceSoft, Inc. Full time

    Job Title: Deviation InvestigatorLocation: Bothell, WA 98021Duration: 12 MonthsJob 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...

  • Deviation Investigator

    4 days ago

    Bothell, United States Axelon Services Corporation Full time

    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) located in Bothell , WA. The Deviation Investigator on the MSAT team is an...

  • Quality Investigator

    2 months ago

    Bothell, United States Net2Source Inc. Full time

    Position: Deviation InvestigatorLocation: 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 have you buy them separately by paying price for the benefits)Client: PharmaBenefits:401K,...

  • Quality Investigator

    2 months ago

    Bothell, United States Net2Source Inc. Full time

    Position: Deviation InvestigatorLocation: 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 have you buy them separately by paying price for the benefits)Client: PharmaBenefits:401K,...

  • Specialist, Quality Assurance Deviation Investigator, Cell Therapy

    4 weeks ago

    Bothell, United States PSG Global Solutions Full time

    At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of Investigator, Quality Assurance, Specialist, Process, Healthcare, Staffing, Support

  • Quality Assurance Operations

    2 weeks ago

    Bothell, United States Omni Inclusive Full time

    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 work cross-functionally and to develop and maintain strong business partner relationships. -...

  • Quality Assurance Specialist

    2 months ago

    Bothell, United States Net2Source Inc. Full time

    Position: Deviation InvestigatorLocation: 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 have you buy them separately by paying price for the benefits) Client: Pharma.Benefits:401K,...

  • Quality Assurance Specialist

    2 months ago

    Bothell, United States Net2Source Inc. Full time

    Position: Deviation InvestigatorLocation: 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 have you buy them separately by paying price for the benefits) Client: Pharma.Benefits:401K,...

  • Senior Quality Assurance Specialist

    4 days ago

    Bothell, United States Axelon Services Corporation Full time

    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 the principles of Client directives. Major duites and responsibilities: ...

  • Quality Assurance Specialist

    16 hours ago

    Bothell, United States SSi People Full time

    Role: Quality Assurance SpecialistContract: 6 MonthsLocation: Bothell, WA (100% onsite)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 Administrator. Compile slides and assemble...

  • Quality Assurance Specialist

    10 hours ago

    Bothell, United States SSi People Full time

    Role: Quality Assurance SpecialistContract: 6 MonthsLocation: Bothell, WA (100% onsite)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 Administrator. Compile slides and assemble...

  • Quality System Manager

    6 days ago

    Bothell, United States Integrated Resources Full time

    Description: Quality Systems support within Quality Operations. Ensure that Client Co. products manufactured at external contract manufacturers are manufactured, tested and released according to established Client specifications and the principles of Client directives. Major duties and responsibilities: • Quality Management System performance metric...

  • Pharmaceutical Quality Support Specialist

    7 days ago

    Bothell, United States TSR Consulting Services, Inc. Full time

    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 years of experience in pharmaceutical Quality Assurance, with direct experience in...