Job Description

Senior Quality Specialist
Job Number: 21-09171
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for Senior Quality Specialist 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:
  • The Senior Specialist QA (CMO) position is an individual contributor role responsible for supporting Supplier Qualification activities and QA oversight of CMO viral vector manufacturing operations in accordance with business agreements and international regulatory and industry standards.
 
Responsibilities:
  • Partner closely with Client's External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners
  • Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners
  • Effectively communicate issues, risks and proposed solutions within the organization
  • Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation
  • Provide communication, support, and guidance to manufacturing partners and within the QA CMO team
  • Conduct reviews of CMO batch records, evaluate deviation investigations, changes and batch disposition
  • Proven ability to work effectively in a matrixed organization
  • Support internal and external audits as needed
  • Create and revise Standard Operating Procedures as needed
  • Other duties as assigned
 
Required Qualifications:
  • Bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or closely related areas
  • 8+ years related industry experience with a minimum of 3 years' experience in quality assurance, quality control, and compliance
  • Knowledge of applicable FDA/EMA regulations in the biotechnology industry
  • Strong organizational skills, including ability to follow assignments through to completion
  • Experience supporting contractor negotiations
  • With moderate oversight from manager, think strategically and understand global impact of decisions
  • Excellent verbal and written communication skills
  • Detail-oriented with demonstrated applications in problem solving
 
Preferred Qualifications:
  • Experience within the Cellular Therapeutics and/or gene-based products
  • Experience with Commercial products manufacture, supply and post-approval change management
  • Experience managing external suppliers and other supply chain issues
  • Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
 
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:
Nica Galang
Monica.Galang@eclaro.com
854-999-0734
 
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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