Job Title :
Change Control Systems Specialist Contract : 2 months (High Chances for Extension) Primary Responsibilities: Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change and document 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 to ensure 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. 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.
Education: Bachelor's degree in a scientific field
Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
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Change Control Systems Specialist Contract : 2 months (High Chances for Extension) Primary Responsibilities: Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change and document 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 to ensure 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. 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.
Education: Bachelor's degree in a scientific field
Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
#J-18808-Ljbffr