Grifols Shared Services North America, Inc Document Specialist / Sr. Document Specialist - Validation in Clayton, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
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.
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Maintain files for documentation in various stages (i.e. current procedures, in circulation for revision and approval, outdated or retired, etc.)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.
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.
Associates degree in a relevant curriculum (i.e. English, Business Administration, etc.)
An equivalent combination of education and experience may be considered.
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.).
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.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 82034
Type: Regular Full-Time
Job Category: Manufacturing