- 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 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.
- 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.
-
Deviation Investigator
3 weeks ago
Integrated Resources Bothell, United StatesJob 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 ...
-
Deviation Investigator
3 days ago
Aequor Bothell, United StatesPosition: 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/ ...
-
Deviation Investigator
3 weeks ago
LanceSoft Bothell, United StatesJob 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 s ...
-
Deviation Investigator
2 weeks ago
LanceSoft, Inc. Bothell, United StatesJob 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 ...
-
Deviation Investigator
3 weeks ago
Axelon Services Corporation Bothell, United StatesPay 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 ...
-
Deviation Investigator
3 weeks ago
Axelon Bothell, United StatesPay 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) ...
-
Deviation Investigator
2 weeks ago
Katalyst Healthcares & Life Sciences Bothell, WA, United StatesResponsibilities: 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 ...
-
Deviation Investigator
4 days ago
TSR Consulting Services, Inc. Bothell, United StatesTSR 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 ...
-
Deviation Investigator
2 hours ago
Axelon Services Corporation Bothell, United StatesPay 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 ...
-
Pharma - Deviation Investigator
5 days ago
Net2Source Bothell, United StatesNet2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We be ...
-
PSG Global Solutions Bothell, United StatesAt 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, Spe ...
-
Quality Investigator
2 weeks ago
Net2Source Inc. Bothell, United StatesPosition: 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 ...
-
Quality Assurance Operations
2 weeks ago
Omni Inclusive Bothell, United StatesJob 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 ...
-
Quality Assurance Specialist
3 days ago
SSi People Bothell, United StatesQuality 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 ...
-
Senior Quality Assurance Specialist
3 days ago
Axelon Services Corporation Bothell, United StatesThis 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 ...
-
Pharmaceutical Quality Support Specialist
3 days ago
TSR Consulting Services, Inc. Bothell, United StatesTSR 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 ...
-
Quality Assurance Specialist
3 days ago
Eclaro Bothell, United StatesJOB 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 ...
-
Investigator I
2 weeks ago
Katalyst Healthcares & Life Sciences Bothell, WA, United Statescommitted 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 ...
-
Quality GMP Specialist
1 week ago
Dexian Bothell, United States Full timeTitle - Quality GMP Specialist · Duration- 06 months · Location- Bothell, WA · Pay range- $40.00 to $42.40/hr · **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · - 3-5 years of GMP work experience · - Familiarity with Batch Records · - Deviations Experience Preferre ...
-
Senior Quality Assurance Specialist
2 hours ago
Axelon Services Corporation Bothell, United StatesPay 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 ...
Deviation Investigator - Bothell, United States - LanceSoft
Description
Job Title: Deviation Investigator
Location: Bothell, WA 98021
Duration: 12 Months
Job Description:
Knowledge, Skills, and Abilities: