Job Description

MSAT Tech Writer
Job Number: 21-16060
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a MSAT Tech Writer 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!
 
Responsibilities:
  • Investigate and write root cause analyses of in-process and end-of-process testing results outside of the specified range during and after drug product manufacturing
  • Compiles and interprets manufacturing process data to identify possible failure modes
  • Learns complex cell biology concepts & applies them to root cause investigations
  • Works independently and with Process Engineer(s) to understand different failure modes
  • Works with GMP Quality Systems to deliver completed Root Cause Analysis investigation reports
  • Facilitates deviation closure through working with quality partners and site quality systems
  • Analyzes and summarizes manufacturing data to support root cause investigations
  • Analyzes and summarizes characterization data to write root cause investigations
  • Utilizes root cause analysis tools such as Kepner Tregoe Problem Solving to identify root cause
  • Writes technical and thorough investigation reports
Required Experience:
  • BS in Bio/Chem Science/Engineering or related field
  • Immunology education preferred
  • 1+ years relevant experience in drug product biopharmaceutical or equivalent industry
  • cGMP/cGDP
  • Ability to prioritize multiple investigations in order to meet deadlines
  • Strong scientific and technical acumen including technical writing skills
Preferred experience:
  • Deviation writing
  • Quality management system
  • Complex problem-solving skills, including root cause investigation
  • Cross-functional collaboration with engineering and quality partners
  • Biologics or cell therapy manufacturing
  • Trained in Kepner Tregoe Problem Solving
 
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: 
June Binuya
junethel.binuya@eclaro.com       
2128047476
June Binuya | 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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