Grifols Shared Services North America, Inc Documentation Specialist/ Sr. Documentation Specialist in Clayton, North Carolina
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.
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 include but are not limited to:
● 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Maintain files for documentation in various stages (i.e. current procedures, in circulation for revision and approval, outdated or retired, etc.)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.
● Since the Document Specialist / Sr. Document Specialist position can be found in multiple Grifols business units which serve the company in different capacities, the job duties of these valuable employees may differ somewhat depending on the needs of the functional areas to which they are assigned. As a result, a key task list form may accompany this job description in the Performance Development database in order to more accurately capture department specific job responsibilities.
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.
Skills/Qualifications/Education: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions)
● Associates degree in a relevant curriculum (i.e. English, Business Administration, etc.)
● The Document Specialist position requires 1 year of relevant experience (i.e. document management, technical writing, administrative/clerical, etc.); The Sr. Document Specialist position requires 3 years of relevant experience (i.e. document management, technical writing, administrative/clerical, etc.)
● 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
- 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 typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, 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
Employee Referral Bonus Eligible
Req ID: 481864