Astrix Technology
Quality Implementation Specialist
Quality Assurance
Warren County, NJ, US
Pay Rate Low: 40 | Pay Rate High: 48
Added - 16/09/2025
Apply for Job
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 environmentThis 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!INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Quality Assurance
Warren County, NJ, US
Pay Rate Low: 40 | Pay Rate High: 48
Added - 16/09/2025
Apply for Job
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 environmentThis 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!INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.