Global Product Development and Supply - Deviation Investigator

Eclaro - Bothell, WA

Full-time - Mid Level

Bothell, WA

Administrative and Support Services

About the position

The Deviation Investigator is a critical role within the Manufacturing Sciences and Technology (MSAT) team at Eclaro's client, a leader in the Biopharmaceutical Industry located in Bothell, WA. This position is responsible for overseeing and managing deviation records through the electronic quality record management system. The Deviation Investigator will investigate various types of deviations, including No Impact, Minor, Major, and Critical deviations, to determine their root causes and corrective actions. The investigator must ensure that all written reports meet regulatory expectations in terms of technical merit and completeness. In this individual contributor role, the Deviation Investigator will operate cross-functionally, collecting necessary data and information related to manufacturing and laboratory investigations. This role is essential in determining corrective actions to prevent the recurrence of deviations. The Deviation Investigator will be a key player in the MSAT team, championing quality principles and compliance within the organization. The position requires a proactive approach to quality and continuous improvement, as well as the ability to anticipate and mitigate challenges that may arise during investigations. The Deviation Investigator will actively manage deviations to achieve right first time (RFT) outcomes and ensure timely phase completion, including the closure of deviations by their original due dates. This role involves collaboration with various stakeholders, including QA reviewers, subject matter experts (SMEs), and other necessary team members, to define and align on investigation plans and required data. The investigator will also facilitate the investigation and corrective action plan (CAPA) processes, ensuring that all actions are implemented effectively and on time.

Responsibilities

• Actively manages deviations to achieve RFT (right first time) and on-time phase completion, including deviation closure by the original due date
• Partners with the investigation team on definition and alignment of the investigation plan, required data, and timing for completion
• Continues to partner with the investigation team throughout the investigation process to ensure agreement on root cause and CAPA
• 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 timely implementation for on-time deviation closure
• Owns and investigates department-specific trend deviations and leads investigation teams for deep-dive analysis
• Facilitates in-depth root cause analysis to determine additional process and system failure modes
• Evaluates previous root causes and CAPA to lessen trends and determine sufficiency of identified CAPA
• Leads GEMBAs and interviews personnel to identify failure modes and understand deviations
• Applies HOP (Human and Organizational Performance) principles to investigations
• Demonstrates good teamwork, collaboration, and communication skills with all internal and external customers
• Completes thorough, accurate, and complete deviations
• Understands overall deviation and CAPA processes, including classifications and requirements
• Captures necessary data to support containment activities and impact assessment
• Attaches all necessary supporting evidence to the electronic deviation and ensures all attachments are referenced in the record
• Performs investigations and root cause analyses commensurate to the event being investigated
• Utilizes good technical writing skills and contacts vendors as needed to complete investigations in a timely manner
• May participate on deviation governance teams, projects, and other initiatives

Requirements

• Minimum of Bachelor's degree in relevant Science or Engineering discipline or equivalent combination of work experience
• 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
• Proven ability to demonstrate attention to detail and personal and team accountability

Nice-to-haves

• Demonstrated ability to work cross-functionally and develop strong business partner relationships
• Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Ability to anticipate and mitigate challenges

Benefits

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro