Job Description

IT Quality & Compliance Specialist
Job Number: 21-09927
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a IT Quality & Compliance Specialist for our client in Bothell, WA.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • Works cross-functionally to support compliance-related activities for GxP electronic systems and applications.
  • This role is an individual contributor, primarily focused on leading investigations and root cause analyses for deviations, and assisting with tracking of Quality Systems commitments (e.g., CAPA and Change Control actions) supporting site computerized systems. The IT Quality & Compliance Specialist will partner with IT, Quality, PMO, Business Owners and Technical Owners to drive completion of Quality Systems deliverables for electronic systems and applications throughout their lifecycle to ensure regulatory and procedural compliance, supporting the site's right to operate.
 
Responsibilities:
  • Perform / lead investigations and root cause analyses for Quality Event deviations related to IT systems
  • Author / contribute / collate content for applicable Quality Systems records, including Deviations, CAPAs, Change Requests, SOPs, and others as needed
  • Provide periodic and ad-hoc status updates for applicable Quality Systems records to site leadership and record owners
  • Track timelines for commitments related to applicable Quality Systems records and prioritize work accordingly
  • Contribute data for department (IT) metrics reporting linked to regulatory compliance and Quality Events, including Deviations, CAPAs, Change Requests, Training, and completion of applicable procedural requirements
  • Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT
  • Perform periodic reviews of applicable SOPs
  • Create / revise SOPs as needed
  • Support regulatory inspections as needed

Qualifications:
  • 5+ years of experience in FDA / EMA regulated industry, biopharmaceuticals or cell therapy manufacturing is preferred
  • 3+ years of direct experience with Quality Systems records (Deviations, CAPAs, Change Controls, SOPs) in a cGMP regulated environment
  • Experience with the use of root cause analysis techniques and methodologies like Fishbone / Ishakawa, Is / Is Not, Pareto Chart (80/20 Rule), Process Mapping, 5-Whys, Contradiction Matrix, and/or Human Error Analysis
  • Experience with the use of Quality Systems records documentation and reporting systems
  • Familiar with diverse computerized systems: MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, Learning Management System
  • Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree or equivalent combination of education and experience is required.
 
Required Skills:
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
  • Strong computer skills with the Microsoft Office application suite and familiarity with various electronic systems used in manufacturing
  • Detail oriented team player with effective planning, organization, and execution skills
  • Proven experience working on teams where combined contribution, collaboration, and results were expected
  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action
  • Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them
  • Extensive experience in Quality Systems processes
  • Good organization and time management skills
  • Ability to work in a high-paced team environment
  • Strong written and verbal skills with proven ability to lead collaborative efforts
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
646-695-2942
Paul Quibuyen | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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