Change Control Systems Specialist

Grifols

Change Control Systems Specialist at Grifols ensuring compliance with FDA regulations for plasma operations. Handle documentation and change requests in a timely manner within manufacturing processes.

Posted 7/18/2026full-timeRTP • North Carolina • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing change control processes in compliance with FDA regulations and cGMP manufacturing practices. Proficient in documentation management, communication across departments, and problem-solving with a strong attention to detail.

Highest-signal resume keywords

FDA Regulatory RequirementsChange Control Process ManagementCGMP Manufacturing PracticesSpreadsheet and Database SkillsOral and Written Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Change Control DocumentationRegulatory ComplianceGood Manufacturing PracticesDocumentation Review and ApprovalProcess Coordination

Soft Skills

Problem SolvingAttention to DetailPrioritizationIndependent Work

Industry Keywords

Food and Drug AdministrationStandard Operating ProceduresPlasma CentersLifecycle Management

About the role

Key responsibilities & impact

Processes change control requests to ensure that process and documentation changes are thoroughly reviewed, justified, documented, and implemented in conformance with regulatory requirements
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 operations
Tracks and maintains change control request documentation throughout its lifecycle: creation/revision, review and approval, implementation, closure
Coordinates change control process to ensure timely delivery of change requests and information to customers
Communicates with other departments to ensure efficient flow of change requests
Prepares changes for review and engages leadership and subject matter experts as needed

Requirements

What you’ll need

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
Attention to detail
Ability to prioritize and work independently with limited supervision

Benefits

Comp & perks

Medical
Dental
Vision
PTO
up to 5% 401(K) match
tuition reimbursement