Job Description

QA Lead Technical Operartions
Job Number: 21-07499
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Lead Technical Operartions for our client in Seattle, 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:
  • Provide oversight and guidance for assigned quality systems and compliance activities across the Client
  • Facilitates quality systems processes, in addition to serving as a key Quality Systems resource for Dexter Corporate office operations and ensuring compliance with applicable policies, procedures and regulatory requirements
  • This position also works cross-functionally to ensure that quality systems processes are harmonized across Client facilities and relevant process improvements are identified, documented and implemented
 
Responsibilities:
  • Contribute to the writing, coordination, review, approval and maintenance of the Client Qualitry Systems Procedures (SOPs) and Work Instructions (WP)
  • Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints, change controls and CAPAs
  • Assure the deliverables, milestones, and objectives for Quality Systems are developed to ensure success for the program(s)
  • Ensure that any changes or impacts to the systems are communicated and agreed to by the Client sites, teams and project sponsors
  • Superuser role for the Quality Systems that fall under hers/his responsibility
  • Develop and conduct user training for Quality Systems for Dexter Corporate Office personnel. This includes new hire and routine training for Quality System elements (i.e. Deviations, CAPAs and Change Control, Quality Risk Management, Document Control)
  • Support and train cross functional groups with guidance on deviation management to ensure accurate reporting, investigation, root cause analysis and corrective actions
  • Perform routine and ad hoc Quality Systems metric reporting and analysis for the Dexter Dexter Corporate Office data
  • Prepare metrics and perform periodic trend analysis in support of Client management review
  • Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders
  • Act as QA Subject Matter Expert (SME) to support cross functional groups for Quality Systems functions
  • Act as a QA SME during internal, external and regulatory audits
  • Support internal, external audits and regulatory inspections. ( data gathering, interviewing or escorting auditors during the audit)
  • Participate in the Risk Management program, including updating risk analyses, participating in applicable teams and maintaining Risk Management documents
  • Support corporate requests for compliance and regulatory assessments
 
Qualifications:
  • Degree in biology, chemistry, engineering or other related field
  • Experience 2+ year's relevant industry experience in a cGMP/FDA regulated environment
  • Preferably 2 years Quality experience with one or more years of experience within Quality Systems
 
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
6466952942
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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