Job Description

Lead QA Technical Operations
Job Number: 20-06210
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Lead QA Technical Operations 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:
  • Provides quality support to client’s site through quality review and approval of investigations and change controls.
  • Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
  • Assures consistent, effective use of the site change control system for all change requests.
  • Ensures supporting documentation and change deliverables meet external regulatory and internal QC guidelines and requirements.
  • May provide Quality support of technical services programs.
  • Represents QA in cross-functional meetings
 
Qualifications:
  • Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline or its equivalent is preferred
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, SmartLAB and Syncade desirable.
  • Past experience where one was required to work in a team based environment with a diverse group of people.
  • Excellent writing and oral communication skills are required.
 
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:
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | 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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