Job Description

Global Product Quality Specialist
Job Number: 21-05328
 
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Global Product Quality Specialist for our client in Summit West, NJ.

 
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:
  • The Global Product Quality Specialist, will be responsible for managing (and owning as needed) documentation and change controls associated with key deliverables to clinical and commercial documentation across multiple programs
  • Functional responsibilities include tracking of multiple work streams and collaborate across multiple functions (i.e. Site QA/QC, manufacturing, validation, IT, manufacturing science and technology, analytical development, etc.) to ensure all technical and compliance requirements are met per clinical and commercial development timelines
  • Support Change control, Deviation and CAPA management, and author and/or review GxP documents as required
  • Provide assistance to other Global Product Quality staff members as needed.
  • Performs other QA duties as assigned.
Qualifications:
  • Minimum of 5-7 years of demonstrated success implementing complex business or technology initiatives
  • Minimum of 3 years working under GMP conditions. BA or BS degree
  • Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams
  • Experience with eQRMS, electronic documentation systems (Veeva), and other quality systems is preferred
  • Experience with owning change controls is required
  • Scientific background with basic understanding of typical analytical methods and Quality Control
  • Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products
  • Detail oriented with high degree of focus. Able to follow instructions and procedures, both written and verbal
  • Able to understand complex work practices
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects
  • Able to perform with minimal supervision and contribute in a team environment
  • Basic knowledge and ability in using Microsoft Office Package
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:
Jane Bautista
froilyn.bautista@eclaro.com
2012858622
Jane Bautista | 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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