Job Description

Quality Assurance Specialist
Job Number: 19-04256
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance Specialist for our client in New Brunswick, 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!
 
Position Overview:
  • Quality Systems support within Corporate Quality.
  • Ensure that Client products manufactured at packaging facilities are manufactured, tested and released according to established Client specifications and the principles of Client directives.
  • Ensure data management of serialized products are compliant and accurately transferred to the relevant entities.
  • In addition ensure effective management of change controls, product quality complaints associated to suspect product and CAPA.
 
Responsibilities:
  • Perform technical assessments in SAP and request support from serialization operations as SME and for resolution when a technical error is identified.
  • Ensure product compliance with current specifications, procedures, and serialization requirements.
  • Data collation, entry, reconciliation, and management of incoming product quality cases.
  • Investigate complaints by researching enterprise-wide systems (SAP) to determined root cause and resolution.
  • Alert management on trends noted during the evaluation of data management.
  • Input all necessary information into applicable enterprise-wide systems (Trackwise & SAP), e.g., lot disposition, product quality complaints, change controls, CAPA.
  • Provides input to management on the need of revision of procedural instructions based on trends, documentation errors or supplemented information.
  • Maintain extensive communication with QRP, ExM, Serialization Operations and other Client groups such as Manufacturing Technology, Supply Chain, and Project Management Serves on Fact Finding or other project teams as assigned
 
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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