Job Description

Quality Disposition and Investigations Specialist
Job Number: 21-10267
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Disposition and Investigations 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:
  • Assist in the start up of the client’s Cell Therapy facility, including:
    • Review of Standards, Procedures, Work Instructions and Training modules
    • Establishing new procedures
    • Establishing business processes to monitor and track routine workload
  • Compile and/or review of disposition deliverables for incoming materials and finished Drug Product
  • GMP inspection and release of incoming consumables, raw materials, and other starting materials
  • Execute inventory and material master transactions in electronic systems such as SAP and Syncade (Manufacturing Execution System)
  • Perform quality review of deviations, CAPA, Effectiveness Reviews and other quality system records in electronic systems (Veeva)
  • Coordinate with global and other cell therapy site functions for alignment
  • Other responsibilities as needed
  • Supervision: Receive general instructions on routine work and detailed instructions on new assignments.
 
Required Qualifications:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
  • Experience in a laboratory, manufacturing, quality, or warehouse environment desired.
  • Ideal candidate is recommended to have a minimum of 2 years of directly relevant experience in a regulated environment.
  • Prior evidence of successful participation on work/study teams where combined contribution, collaboration, and time bound results are expected.
  • Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications, as well as ERP solutions such as SAP.
  • Work/study experience where attention to detail and personal accountability were critical to success.
  • Previous work experience where attention to detail and personal accountability were critical to success.
  • Strong communication skills and the ability to follow written and verbal instructions.
 
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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