Job Description

Quality Assurance
Job Number: 21-03428
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance for our client in Groton, CT
 
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Providing Clinical Packaging expertise to our stakeholders, while maintaining an organizational culture that values flexibility, continuous improvement and an agility to meet business needs
  • Work with the Supply Chain Leads (SCL), Operational Strategy Lead (OSL), and Clinical Research Pharmacist (CRP) to review and interpret the clinical protocol to develop practical and efficient packaging designs for Clinical Supplies
  • Coordinate and communicate multiple study packaging and/or labelling requirements across a network of global packaging vendors and internal packaging facilities
  • Be compliant with cGMPs when ensuring the delivery of clinical supplies
  • Utilize Project Management skills to plan, schedule and assess risks to complete the packaging operation
  • Prepare/Approve packaging documentation and generate internal study paperwork to support packaging operations
  • Review internal/contractor packaging and labelling documents making recommendations where appropriate to ensure compliance with Clinical Supply Packaging procedures, study requirements and Good Manufacturing Practice (cGMPs)
  • Work with Inventory Management, Quality Assurance and Global Analytics to co-ordinate and drive the progress of the packaging operation to ensure timelines are met
  • Facilitate the use of Clinical Supply Distribution System (CSDS) for importing packaged inventory for distribution purposes
  • To support assigned Global Clinical Supply or Clinical Supply Packaging continuous improvement initiatives
 
Qualifications:
  • B.S. degree within a scientific discipline or 5 years equivalent experience in Supply Chain
  • PMP certification or demonstrated project management experience
  • Experience working in a GMP regulated work environment
  • Proficiency in Microsoft office and enterprise wide applications or systems (e.g. Clinicopia, CSDS, GDMS)
 
Preferred Qualifications:
  • Knowledge of clinical trial study designs
 
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
6466952942
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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