Job Description

QA Associate
Job Number: 20-09048
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate 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:
  • Maintains shop floor quality presence; releases, in-process materials, and finished product; investigates and resolves deviations and complaints; conducts annual product reviews.
  • Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines.
  • May assist in preparing for a hosting of regulatory and customer audits.
  • Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
  • Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
  • Drafts and reviews specifications and SOPs.
  • Reviews and approves discrepancy reporting, investigations and CAPAs associated with incoming, in-process and production batch processing.
  • Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
  • May provide guidance to less experienced staff.
 
Experience:
  • 5+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Strong communication skills and demonstrated ability to influence stakeholders is required.
 
Preferred Qualifications:
  • B.S. in Chemistry, Chemical Engineering, Biochemistry or related discipline, or its equivalent
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing
  • Knowledge of SAP, LIMS, Delta V, Maximo, Syncade are a plus
  • Knowledge of integrated electronic systems, including electronic batch record review is highly desirable.
 
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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