Validation Document Specialist / Senior Documentation Specialist

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.

 

Summary:                                                        

The Document Specialist / Sr. Document Specialist is responsible for initiating as well as maintaining a variety of documents in support of Manufacturing Operations and/or Research & Development (R&D).  May work in one of the following business units:  Manufacturing, Quality Operations, Engineering, Validation, Research & Development, etc.  

 

The Document Specialist / Sr. Document Specialist may also be responsible for tracking documents through the approval process as well as maintaining current revision and historical changes for controlled document files.   He/she will operate a computer in order to complete the majority of his/her job duties.  At times the Document Specialist / Sr. Document Specialist may be required to perform miscellaneous administrative tasks for the business unit that he/she supports.

 

Primary responsibilities for role:                                                 

• Initiate, track, and maintain with accuracy a variety of documents used in support of Manufacturing Operations or Research & Development.  Documents initiated, reviewed, and/or maintained include but are not limited to the following:  batch production records (BPRs), standard operating procedures (SOPs), logbooks, product technical complaints (PTCs), manufacturing and raw material purchase

   specifications, contractor badge access, training, and qualification forms, metrics or tracking spreadsheets/charts, various weekly/monthly/quarterly reports, etc.

• Maintain files for documentation in various stages (i.e. current procedures, in circulation for revision and approval, outdated or retired, etc.)                                                     

• Distribute new and revised documents to designated stakeholders.                                                 
• May coordinate and perform routine audits of documents maintained in order to ensure that all documents are accounted for and current.                                                           
• May perform miscellaneous administrative tasks for business unit.                                    
• Adhere to all GMP, safety, and training requirements.                                                      
• The Sr. Document Specialist is highly skilled and proficient in the area that he/she supports.         
• As a documentation Subject Matter Expert (SME), the Sr. Document Specialist may be asked to mentor or train other Document Specialists.                                                      
• Other duties as assigned and deemed appropriate for the position.

 

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

 

Knowledge, Skills, and Abilities:

Incumbent must be proficient in the use of computers and other standard office equipment.  Proficiency in the use of computer software such as Microsoft Office (i.e. Excel, Word, etc.) and excellent communication skills (verbal and written) are required.  The Document Specialist / Sr. Document Specialist must be able to work independently with a high degree of accuracy; be able to manage multiple tasks to ensure timely and accurate completion of all assignments; and be able to identify discrepancies in documentation and follow up with appropriate personnel to resolve the discrepancies.

 

Education and Experience Requirements:                                                           

Document Specialist     

Associates degree in a relevant curriculum (i.e. English, Bus