Job Description

QA Specialist
Job Number: 21-08705
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA 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!
 
Position Overview:
  • The QA Specialist will project manage the lifecycle of material qualifications used to manufacture biologics (large molecules) drug substances.
  • The scope of work will range from supplier selection, material assessment, document creation / revision, review, approval and material release for use performed by QA Operations.
  • Also includes tracking / documenting completion of tasks in the change management system within defined implementation timelines.
 
Responsibilities:
  • Work activities will include exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Resolves simple problems in addition to identifying and assessing risks
  • Requires work to be completed and measured based on meeting established timelines, objectives and schedules
  • Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions
 
Qualifications:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent
  • A minimum of 4 years with directly relevant experience in a regulated environment is required
  • Knowledge of regulated activities such as Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs)
  • Demonstrate proficiency in common computer tools such as word processing, spreadsheet and web based applications
  • Past experience where one was required to work in a team based environment with a diverse group of people
  • 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:
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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