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.

Documentation & Change Specialist

Summary:

This position will articulate and illustrate technical data into clear, simple language for end users to follow and easily understand. Responsibilities of this position include, but are not limited to, formatting and editing documents, including Standard Operating Procedures, Specifications, Controlled Forms, and other documents that support GMP operations and comply with cGMP and FDA guidelines, and additional quality standards. This position also coordinates the review and approval of controlled documents. Processes change requests and controlled documents in electronic system 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:

• Provide technical word processing for new and revised documents that may include preparing complex tables, footnotes, equations, and graphics.

• Function as the starting point for most new and revised technical documentation.

• Enhance / re-design current documentation.

• Assist with Document Control daily/weekly/monthly tasks including, but not limited to issuance of documents for use in whole blood and source plasma donor centers, manufacturing and production; perform documented impact assessments; initiation of Periodic Review workflows; QA-to-QA file transfers.

• Perform technical editing of user documents which includes, but is not limited to; proofreading, collaborating on analyzing edits, adjudicating redlines, and assisting troubleshooting format.

• Assist with oversight of the document change management library, including document uploads, impact assessment, approval management and change governance.

• Work closely with Donor Center, Whole Blood Processing and Manufacturing management to create complete and comprehensive documentation.

• Advise management on the proper prioritization of documents associated with business initiatives.

• 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.

• Work closely with Donor Center, Whole Blood Processing and Manufacting management to create complete and comprehensive documentation.

• Additional duties as assigned by management.

• 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.

• 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 andcompletion of all actions required by the change have occurred. Coordinates training on Change Control procedures.

• Authors Center Notifications as needed to communicate non-procedural updates to the donor centers and leadership.

• Maintains a master library/database of all change request documents. Maintains secured filing and storage system for archived hard copy change requests.

• Manages Quality System documentation throughout its lifecycle to process, distribute and track. Maintains Quality System documentation through creation/revision, review and approval, effectivity, and obsolescence. Distributes customer specification documents to departments and point-of-use locations.

• Maintains electronic document control system (i.e., DCM), and controls electronic versions of documents and archived files that exist outside of the electronic document control system.

• Prepares/proofs document content and formatting for all documents. Coordinates with document authors, owners, and reviewers to resolve content and formatting concerns prior to issue.

• Maintains a master library/database of all SOPs, forms, job aids, and training documents. Maintains secured filing and storage system for archived hard copy-controlled documentation.

• Maintains document control calendars, databases and ensures document control procedures are updated according to established procedures and standards.

• Responds to customer service requests, and assists other departments, as needed.

Additional Responsibilities, Skills & Education:

• 5-10% Travel.

• Intermediate to advanced computer skill in Microsoft Word, Outlook, Excel.

• Good understanding of Good Manufacturing Practices (GMPs).

• Excellent interpersonal and communication skill.

• Must possess customer service skills and display attention to detail.

• Experience with Document Change Management system a plus.

• Must be flexible and able to multi-task in a fast-paced environment, and team player.

• Must be able to proof work and identify non-standard format or wording and errors within documents.

Associates degree or higher

Benefits:

Pay scale of $77,007.45 - $115,511.75 for California based employees, This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

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 in a manner consistent with the requirements of applicable state and local laws

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 519072

Type: Regular Full-Time

Job Category: Regulatory Affairs