Summary:
Processes change control requests to ensure that process and documentation changes with the potential to impact the safety, purity, potency, and quality of manufactured product are thoroughly reviewed, justified, documented, approved, and implemented in conformance with regulatory requirements and company policies / procedures.
Primary 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.
Knowledge, Skills and Abilities:
- 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.
Education and Experience:
- Bachelor's degree in a scientific field.
- Typically requires 5 years of related experience.
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
