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Quality Implementation Specialist

Quality Implementation Specialist

Astrix IncWarren, NJ, United States
3 days ago
Job type
  • Full-time
Job description

Quality Implementation Specialist / Manager

Contract to Hire

Warren County, NJ

Pay : $40-48 / hour

About the Role :

The Project Implementation Manager leads and coordinates cross-functional teams to deliver projects that support our growth and continuous improvement goals. These projects may include expanding production or testing capacity, transferring products, improving processes, or ensuring regulatory compliance. The role ensures all projects are completed on time, within scope and budget, and meet industry standards such as cGMP, ISO, and FDA regulations.

Key Responsibilities :

  • Plan and manage projects involving production, testing, product transfers, process improvements, and regulatory compliance
  • Collaborate with internal teams and external partners to define project scopes and objectives
  • Develop and track detailed project plans
  • Monitor project progress and performance using tracking tools and systems
  • Lead meetings, manage project risks, and ensure timely communication with stakeholders
  • Prepare teams for milestone (tollgate) reviews and ensure project readiness
  • Escalate issues and drive resolution of project roadblocks
  • Ensure compliance with regulatory standards (e.g., cGMP, FDA, ISO, ICHQ7, IPEC)

Required Qualifications :

  • Bachelor's degree in Business, Project Management, Science, or Engineering (advanced degree a plus)
  • 5+ years of experience in project management within regulated industries (e.g., pharmaceutical, biotech, or chemical)
  • Strong understanding of regulatory requirements including cGMP, FDA (21 CFR Part 11, 210 / 211), and ISO standards
  • Experience with quality, regulatory, or IT systems is a plus
  • Project management training required; certification preferred (PMP, PRINCE2, etc.)
  • Excellent communication, leadership, and organizational skills
  • Ability to work cross-functionally in a matrixed environment
  • This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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    Implementation Specialist • Warren, NJ, United States

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