Job Description

Reference # : 18-09236Title : Quality Assurance Specialist
Location : New Brunswick, NJ
Position Type : Contract
Experience Level : Start Date / End Date : 10/24/2018 / 04/23/2019
Assignment Detail
Industry:Biotech/PharmaJob Category:QA / QC
Description
Quality Assurance Specialist

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance Specialist for our client in New Brunswick, 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!

Responsibilities:
  • Provides quality and compliance oversight to clinical packaging operations ensuring compliance with company directives and governmental regulations.
  • Perform all product release activities, which include, but are not limited to, review of batch records, and other associated GMP documentation.
  • Ensures that disposition decisions (release or reject) are entered into the inventory management system.
  • Review clinical label proofs for approval, and clinical label documents for release.
  • Review and approval of all documents related to the Quality System such as investigations into quality incidents & manufacturing deviations, corrective and preventative actions, procedural documents, to ensure conformance to cGMP, Client standards and global regulatory requirements.
  • Supports the site compliance function during regulatory agency and third party inspections.
  • Provides guidance on quality issues to the Packaging group.
  • Escalates immediately to the supervisor, any issues impacting product quality

Qualifications:
  • Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy, biology or a related pharmaceutical science
  • In-depth knowledge of cGMP regulations
  • Strong problem solving, interpersonal and organizational skills

Required Experience:
  • Minimum of 5-7 years’ experience in pharmaceutical quality and/or operations at a site level
  • 2-4 years’ experience in a regulated function

Preferred Experience:
  • Experience within a QA/QC environment
  • Experience with clinical packaging

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

Interested in applying? Contact Jane Bautista at (201) 285-8622 or at https://www.linkedin.com/in/froilyn-jane-bautista-88751612a or send your resume to Jane@eclaro.com now.

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

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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