Quality Systems Associate – Change Control

Gravity IT Resources

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Job Description:

The Quality Systems Specialist – Change Control will bring their knowledge and experience in service to patients and pursuit of excellence in quality and compliance.
Responsibilities of the position include but are not limited to oversight of the quality management system (QMS) change control program.
The role is essential to ensure the site’s Change Control Program complies with applicable regulatory standards (e.g., Current Good Manufacturing Practices) and expectations for the development and reliable supply of quality medicines and reliable supply of quality medicines.

Essential Duties and Responsibilities:

  • Responsible for the Quality Management System oversight and execution of the Change Control Program.
  • Reviewing, editing, and approving change control documentation to ensure compliance with quality, regulatory, and SOP requirements.
  • Scheduling and facilitating cross-functional change control meetings and providing guidance and consultation to change control owners.
  • Facilitate, monitor, and drive change control on-time completion.
  • Support overall quality system programs as needed to include but not limited to document control, supplier quality, and investigation systems.
  • Track, trend, and analyze QMS change control metrics for the site.
  • Developing collaborative relationships with end users and providing guidance on standard processes in Change Control.
  • Act as the site’s subject matter expert on changed control.
  • Partnering with members of the Quality Assurance team and/or end users of the system to promote continuous improvements to the Change Control system, process, and associated procedures.
  • Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.
  • Support cGMP compliance and inspection readiness within the organization.
  • Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
  • Fosters the development of a Quality Culture within the cGMP environment.
  • Practice and promote a safety and quality mindset and quality excellence approach to all activities. 
 

Basic Qualifications and Capabilities:

  • Bachelor’s degree with a minimum of 4+ years of document control experience within a regulated industry or a combination of equivalent education and experience.
  • Led a cGMP Change Control program.
  • Strong organization, and execution skills with an attention to detail.
  • Ability to successfully manage multiple priorities.
  • Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills, and share knowledge with others.
  • Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
  • Interact with other functions and be able to take ownership of and follow through on assigned projects.

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