Quality Systems Change Coordinator

2 weeks ago

Round Lake Beach, Illinois, United States BioSpace, Inc. Full time
Position Overview

As a pivotal member of our team at BioSpace, Inc., the Quality Systems Change Coordinator will take on the essential role of managing and overseeing Quality Systems Change Control processes. This position requires a deep understanding of change management and documentation practices, ensuring that all changes are meticulously documented and executed in compliance with established guidelines.

Key Responsibilities:
  • Develop and manage change control documentation for manufacturing processes and maintenance activities.
  • Oversee the closure of Level 1 and Level 2 changes, ensuring that all actions and tasks are appropriately assigned to relevant teams.
  • Monitor and report on change control performance metrics to ensure compliance with key performance indicators (KPIs).
  • Facilitate communication and coordination of change control documents using various systems.
  • Engage with cross-functional teams during change control review sessions to uphold quality and compliance standards.
  • Compile and create technical reports based on change control requirements.
  • Revise and format documentation, including standard operating procedures (SOPs) and product specifications.
  • Coordinate regular reviews of manufacturing-related documents to ensure accuracy and compliance.
  • Participate in safety and continuous improvement initiatives within the organization.
  • Lead collaborative efforts, fostering teamwork and problem-solving to address technical and operational challenges.
  • Respond to inquiries from management and stakeholders regarding change control processes.
  • Identify opportunities for process enhancements to drive continuous improvement.
  • Develop management tools for tracking project progress and performance metrics.
  • Ensure data integrity and adherence to company standards and regulatory requirements.
  • Support production needs through various operational activities.
  • Possess knowledge of critical manufacturing processes and equipment.
  • Demonstrate an understanding of scientific methodologies to innovate processes.
  • Utilize experience with relevant systems to enhance operational efficiency.
  • Apply good manufacturing practices (GMP) and meet environmental health and safety (EHS) standards.
Qualifications:
  • A bachelor's degree in a relevant field such as science or engineering is typically required.
  • A minimum of 5 years of experience in a related role is preferred.
Work Environment Considerations:
In this role, you may be required to work in controlled environments that necessitate specific safety protocols. Flexibility in working hours may be necessary to meet production and validation objectives.

About BioSpace, Inc.:
At BioSpace, we are dedicated to advancing patient care through innovative pharmaceutical solutions. We pride ourselves on fostering a collaborative and inclusive workplace where our employees are empowered to contribute to meaningful work that impacts lives globally.

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