Grifols · 7 hours ago
Change Control Systems Specialist
North Carolina, United States
Full-time
Onsite
Senior Level
5+ years expGrifols is a global healthcare company dedicated to improving health and well-being since 1909. The Change Control Systems Specialist processes change control requests to ensure compliance with regulatory requirements and company policies, overseeing the documentation and implementation of changes in manufacturing processes.
BiotechnologyHealth CareManufacturing
Responsibilities
Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change control
Processes change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and plasma operations, including but not limited to: product manufacturing / procedural changes, equipment changes, customer changes, supplier (contractor) changes, and facility changes
Tracks and maintains change control request documentation throughout its lifecycle: creation/revision, review and approval, implementation, closure. Ensures tasks are completed in a timely manner
Coordinates change control process to ensure timely delivery of change requests and information to customers, including plasma centers and plasma operations, as required
Communicates with other departments, including Corporate, Field management, and Center-level customers to ensure efficient flow of change requests and information pertaining to shared/impacted processes
Communicates with Training Department and Document Control to facilitate Center and Corporate training related to Change Requests
Reviews / evaluates supporting document content and formatting for all change requests. Facilitates with change requestors, change owners, and reviewers to resolve concerns prior to and during implementation of the change
Prepares changes for review, and engages leadership and subject matter experts as needed to facilitate the change control process
Performs final review of change requests and its documentation to ensure completeness, including documented evidence of impact assessments as a part of risk management and completion of all actions required by the change have occurred. Coordinates training on Change Control procedures
Responds to customer service requests, and assists other departments, as needed
Maintains a master library/database of all change request documents. Maintains secured filing and storage system for hard copy change requests
Develops metrics for the department. Prepares and submits metrics reports and updates on change control activities
Qualification
Required
Bachelor's degree in a scientific field
Typically requires 5 years of related experience
Strong knowledge of Food and Drug Administration (FDA) regulatory requirements for good manufacturing practices
Demonstrated spreadsheet and database computer software skills
Excellent oral and written communication skills
Strong problem solving skills, with ability to follow assigned tasks through to completion
Attentive to detail. Ability to prioritize and work independently with limited supervision
Benefits
Medical
Dental
Vision
PTO
Up to 5% 401(K) match
Tuition reimbursement
Company
Grifols
Grifols is a global healthcare company.
10001+ employees
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Camille Alpi
Chief Human Resources Officer
Víctor Deu
Director of Planning & Control Department
Recent News
2025-12-24
Pharma Letter
2025-11-28
2025-11-19
Company data provided by crunchbase