Job Description

QA Specialist
Job Number: 21-12990
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Specialist for our client in Devens, MA.
 
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:
  • Provides support through quality review and approval of GMP Material & service non-conformances with suspected supplier root cause.
  • Provides quality oversight of supplier complaints.
  • Reviews and approves supplier investigations and CAPAs.
  • Represents Quality in cross-functional meetings and with suppliers.
  • Assist in resolution of supplier / material related issues as they arise.
  • May perform quality review for area documents including Standard Operating Procedures, Batch Records, Material Specifications, forms and logbooks
 
Qualifications:
  • Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline, or its equivalent.
  • A minimum of 4 years with directly relevant experience in a regulated environment is required; biotech bulk and finished product manufacturing is highly desirable.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of quality management systems, including TrackWise or Infinity, is desirable.
  • Past experience where one was required to work in a team-based environment with a diverse group of people.
  • Excellent writing and oral communication skills are required.
 
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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