quality assurance in bridgewater

job type
US$ 55,000 per year
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job details

bridgewater, new jersey
job category
Biotechnology & Pharmaceutical
job type
US$ 55,000 per year
reference number
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job description

Job Title: Quality Systems Associate

Position Description

  • Incumbent will work with a cross functional team located in Bridgewater, NJ to support and continuously improve the Quality System.
  • The main focus of the position will be to ensure appropriate and well-maintained systems are in place to support the team within development and GXP operations performed.
  • The Quality Systems Associate reports directly to the Quality Systems Manager.

Position Responsibilities

  • Manage the routing and formatting of development and GXP documents as they are moved through the review and approval process in electronic documents system. This includes maintaining the system for required hard copy documents, including secure storage, retrieval, retention and destruction.
  • Maintain and deliver training and/or guidance on document and records management roles and processes.
  • Support the Quality Review Team and Change Control Committee on a routine basis.
  • Ensure proper documentation of internal and external audit responses (corrective actions) and drive audit closure.
  • Prepare quality metrics reports on a routine basis.
  • Support the company with regulatory inspection readiness activities.
  • Department director may assign other responsibilities as required.

Position Requirements

  • Ideal candidate would possess a background in electronic and or paper based Quality Systems.
  • Minimum 3 years of experience in pharmaceutical industry or at least 2 years in QA or regulatory affairs role.
  • BS degree Life Sciences is preferred; however, equivalent experience will be considered.

Technical Skills

  • Experience with electronic Document and Training modules is a plus.
  • Solid working knowledge of pharmaceutical quality system requirements and international regulatory requirements.
  • Strong written and oral communication skills.
  • Must be highly organized with attention to detail and capable of multi-tasking and used to a fast pace environment.
  • Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of various factors.
  • Advanced knowledge of computer software in order to perform trending and prepare presentations to management (MS Word, MS Excel, MS PowerPoint, etc.)
  • Good knowledge & application of FDA regulatory requirements and industry standards related to cGMP document management.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.