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We have an opportunity for Deviation Investigator withDirect Client . Below is the detailed job description along with the client details and work location. If you are in the market or looking for a change please respond with the following information or do call me at 609-454-3209 Ext 116.
Position Details:
Job Title: Deviation Investigator
Location: Bothell, WA
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 management system 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 MSAT team and a champion for quality priority principles and compliance within the organization.
Minimum of Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.
Knowledge, Skills, and Abilities
Key Responsibilities
o Assess trend details to ensure accuracy and alignment across the team
o Facilitate in-depth root cause analysis to determine additional process and system failure modes
o Evaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trend
o Determine if previous identified CAPA are sufficient to reduce the trend by defined targets
o Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
o Seeks to understand, demonstrates humility, and shows curiosity for learning
o Completes deviations that are thorough, accurate, and complete
o Understands the overall deviation and CAPA processes including all phases of the records and proper content for each phase
o Understands appropriate assignment of classifications and requirements for each
o Understands the importance and impact of lot association within deviations and the relation to product disposition
o Captures the necessary data to support containment activities and impact assessment
o Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments have been referenced in the record
o Performs investigations and root cause analyses that are commensurate to the event being investigated
o Understands multiple RCA tools and when, where, and how to apply them
o Utilizes good technical writing skills
o Contacts vendor as needed to complete investigations in a timely manner
o May participate on deviation governance teams, projects, and other initiatives
"IND1"
Job Type: Contract
Pay: $50.00 - $67.00 per hour
Schedule:
Work setting:
Work Location: In person
Contractor
IT Outsourcing & Consulting
$65k-86k (estimate)
07/11/2024
07/19/2024
fortira.com
PRINCETON, NJ
50 - 100
1996
CHRIS KAMBHAMPATI
$5M - $10M
IT Outsourcing & Consulting
At Fortira, we completely understand that each of our customer's needs are different and our solutions are just that- Tailor-made for you. Customisation with minimum cost but maximum success is the defining goal of each of our services. Our certified professionals are trained to translate your complex hardware, software and network environments into effective business processes and help you in deriving optimum returns on your investments. Although we deal with some of world's most reputed and largest companies, but your size quite honestly is the last thing on the back of our minds. With a sha...rp eye on delivering quality and adept at cross-technology methods, a challenging situation is what we aspire for and our services will change the way you do business. We believe in deploying robust business applications as soon as we possibly can, working around the clock in an efficient way. Our wide range of service offerings, we believe will help you in making the most of your IT investments. Services : Near Shore Services. Infrastructure Management, Technology, Consulting, Life Sciences Vertical, DevOps Consulting Services, Azure Consulting Service, Microsoft Dynamics ERP and CRM, Software Solutions, Mobile App Development.
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