Job Description

QA Specialist
Job Number: 20-06169
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for 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:
  • Works cross-functionally with lead investigators, subject matter experts, and supervisors within the GMP functions to support investigations and CAPAs at the Devens site
  • Provides oversight and guidance for deviation assessment, impact assessment, root cause analysis and CAPA planning activities
  • Performs review and approval of investigations, CAPAs, and effectiveness reviews in the Quality Management System
  • Key Core behavioral indicators for this role include:
    • Participates in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.
    • Demonstrates appropriate examples of compliance behaviors and attitudes.
    • A high degree of accountability and matrix leadership is critical.
 
Required Qualifications:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.
  • A minimum of 4 years relevant experience with a minimum of 2 years in a regulated environment.
  • Knowledge of Investigations and/or CAPAs is highly desirable.
  • Knowledge of biotech bulk and finished product manufacturing, and/or analytical testing, is highly desirable.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Excellent writing and oral communication skills are required.
  • Previous work responsibility, which required a high degree of attention to detail.
  • Well practiced in exercising sound judgment in decision-making.
  • Past experience where one was required to work in a team based environment with a diverse group of people.
 
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:
Maria Castañeda  
maria.castaneda@eclaro.com   
6463571235
Maria Castañeda | 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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