Job Description

QC Training Specialist
Job Number: 21-09070
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QC Training Specialist for our client in Summit, 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!

  • The QC Training Specialist is responsible for supporting Quality Control method training for release of clinical products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, this position will participate in supporting document management, projects, CAPAs and investigations in accordance with the organizations policies, procedures and state, federal and local laws and compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times
  • Performs routine laboratory training on Bioanalytical techniques, such as ELISA, cell culture, qPCR, and FACS
  • Utilize scientific principles to assist in laboratory testing methods and the proper use of laboratory equipment
  • Understands regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents
  • Work and communicate effectively within the team to ensure timelines are met
  • Review data in accordance with applicable procedures and cGMP requirements
  • Perform assigned tasks and track timelines within a training project
  • Communicate effectively with management regarding task completion, roadblocks, and needs
  • Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles
  • Performs other tasks as assigned
  • Assists with developing best practices in the QC laboratory
  • Use technical expertise to train, troubleshoot and solve problems that may come up in the day to day operation of the department.
  • Capable of handling complex issues and solving problems with minimal guidance
Required Qualifications:
  • Hands on experience with various laboratory techniques and environmental monitoring.
  • Ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements.
  • Problem solving ability/mentality, technically adept and logical
  • Ability to work with management locally and globally
  • Follow directions well; work cooperatively as a team leader, an individual contributor and as a team member
  • Advanced written and verbal communication skills
  • Ability to work under limited supervision
  • Communicates effectively with peers, management and cross-functionally across the site
  • Critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments
  • Ability to deal appropriately with regulatory agencies and act as a Subject Matter Expert (SME) for the department during regulatory and non-regulatory inspections
  • Bachelor's degree, particularly in a Biology, or Biochemistry related field, required
  • 1-3 years relevant work experience required, preferably in a manufacturing environment with cGMP requirement
  • An equivalent combination of education / experience may substitute

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:

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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