Change Control Systems Specialist

2 weeks ago

Durham, North Carolina, United States Biomat USA Full time
Job Summary

We are seeking a highly skilled Change Control Systems Specialist to join our team at Grifols. As a key member of our manufacturing operations, you will be responsible for ensuring compliance with regulatory requirements and company policies/procedures related to change control.

Key Responsibilities
  • Process change control requests to ensure thorough review, justification, documentation, approval, and implementation of process and documentation changes that may impact product safety, purity, potency, and quality.
  • Ensure compliance with FDA regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change control.
  • Track and maintain change control request documentation throughout its lifecycle, ensuring timely completion of tasks.
  • Coordinate change control process to ensure timely delivery of change requests and information to customers, including plasma centers and plasma operations.
  • Communicate with other departments, including Corporate, Field management, and Center-level customers to ensure efficient flow of change requests and information.
  • Review and evaluate supporting document content and formatting for all change requests, facilitating resolution of concerns prior to and during implementation.
  • Prepare changes for review, engaging leadership and subject matter experts as needed to facilitate the change control process.
  • Perform final review of change requests and its documentation to ensure completeness, including documented evidence of impact assessments and completion of all required actions.
Requirements
  • Bachelor's degree in a scientific field.
  • Typically requires 5 years of related experience.
  • Strong knowledge of FDA regulatory requirements for good manufacturing practices.
  • Excellent oral and written communication skills.
  • Strong problem-solving skills, with ability to follow assigned tasks through to completion.
  • Attentive to detail, with ability to prioritize and work independently with limited supervision.
What We Offer

Grifols offers a wide variety of benefits, including medical, dental, vision, PTO, up to 5% 401(K) match, and tuition reimbursement. This position is eligible to participate in up to 5% of the company bonus pool. We are committed to offering our employees opportunities for professional growth and career progression.

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