Change Control Systems Specialist - Durham, United States - Biomat USA

Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

This is a hybrid-remote role based out of our RTP, NC office.

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.

This position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us

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.

This position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Learn more about Grifols )

Req ID: 514747

Type: Regular Full-Time

Job Category: Manufacturing