Job Description

Quality Assurance Specialist
Job Number: 19-10368
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!
Position Overview:
  • PDQ Good Manufacturing Practice (GMP) department serves as the Quality Assurance Unit
  • Overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP/GDP) and other applicable regulations and internal procedures.
  • Key responsibilities will include batch disposition (release/reject decision), audit of internal GMP systems/processes and suppliers/third party contractors, as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.
  • Performs quality release activities for all clinical trial materials packaged and labeled (in-house and/or under contract) to ensure the standards of Client and regulatory agencies (FDA, EU, etc) are met.
  • This includes working with Functional Area to address deviations/investigations.
  • Works collaboratively with the CSO- Packaging and Labeling, Operations Planning and Support, and Regional Logistics areas to ensure continued compliance with Client procedures and regulatory expectations.
  • The positions reports to the Director, New Brunswick Quality, with job responsibilities that include but are not limited to:
    • 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, as well as self-inspection requirements.
    • Provides guidance on quality issues to the CSO - Packaging and Labeling, Operations Planning and Support, and Regional Logistics.
    • May participate in Vendor/ Contractors Qualification activities as assigned.
    • Escalates immediately to the supervisor, any issues impacting product quality.
Required Qualifications:
  • Knowledge of science generally attained through studies resulting in B.S. or M.S. in chemistry, pharmacy, biology or a related science
  • Minimum of 5-7 years’ experience in pharmaceutical quality and/or operations at a site level, including 2-4 years’ experience in a regulated function, preferably GMP.
  • Experience with batch record review is an asset
  • Experience with clinical packaging is an asset
  • In-depth knowledge of cGMP regulations
  • Strong problem solving, interpersonal and organizational skills
  • Ability to work with many different computer systems/platforms.
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:
Antonette Dizon

Antonette Dizon | 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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