Grifols Jobs

ust_building]] </strong></p><p></p><p><a href="http://www.grifols.com/es/web/international/home" target="_blank">Learn more about Grifols</a></p><p></p><br><strong>Req ID:</strong> 419227 <br><strong>
able.MiTabla { max-width: 1020px;!important </p><img align="top/" alt="" src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_06_GPO.jpg/a5d80af4-bb13-a8cd-d567-ea1e87192f07?t=1636640424362"><p style="text-align:justify">Do you want to join an international team wor
vices in more than 100 countries and regions. </p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"><p style="text-align:center"><strong>This position is based out of our RTP Office
ities/Females/Disability/Veterans </strong></p><p><strong>#biomatusa </strong></p><p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p><p><strong>Location: [[mfield6]]:[[cust_building]] </strong></p><p></p><p>

Job Information

Biomat USA, Inc. Change Control Specialist in Los Angeles, California

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

This position is based out of our RTP Office. This is a hybrid remote schedule.

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.

Occupational Demands Form # 9: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

EEO Minorities/Females/Disability/Veterans

#biomatusa

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols

Req ID: 419227

Type: Indefinido tiempo completo

Job Category: Producción en industria Química/Farmacéutica

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