Deviation Investigator - Bothell, United States - TSR Consulting

Description

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:
$62-63/hour W2

Required Skills:

Responsible for overseeing and supporting the management of deviation records through the electronic quality record management systemResponsible 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 expectationsThis 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 reoccurringThis person will be a key player and a champion for quality priority principles and complianceExperience in FDA/EMA regulation in the biotechnology and/or cellular therapy field is preferredExperience working within quality systems managing deviation and CAPA recordsExperience authoring deviation and CAPA recordsExpertise in GMP compliance and FDA/EMA regulationsActively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due dateImmediately 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 CAPAWhen CAPA are needed, facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirementsEnsures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely to ensure on-time deviation closureOwns and investigates department-specific trend deviationsLeads investigation team to perform deep-dive analysis of department-specific trendsAssess trend details to ensure accuracy and alignment across the teamFacilitate in-depth root cause analysis to determine additional process and system failure modesEvaluate previous root causes and CAPA (in-progress or implemented) identified to lessen the trendDetermine if previous identified CAPA are sufficient to reduce the trend by defined targetsLeads GEMBAs and interviews the people closest to the work to identify failure modes and seek further understanding of the deviationsApplies HOP (Human and Organizational Performance) principles to investigationsUses both soft-skills and technical skills to drive the deviation and CAPA processes#J-18808-Ljbffr