Document Control Specialist
Document Control Specialist
Summary: It is the responsibility of the Document Control Specialist to create, manage and maintain GMP documents, which include but are not limited to: Standard Operating Procedures, Master Manufacturing Records, Production Batch Records, test data sheets, MSDS’s, controlled forms, deviation records and other GMP related documents.
Duties and Responsibilities:
- Manage document processes and systems to ensure control and availability of documentation to site personnel.
- Coordinate the creation , revision, and distribution of controlled documents to plant management.
- Assign control number to Document Change Requests.
- Format documents submitted to Document Control
- Review change request documents to assure accuracy and completeness.
- Review and approves Master Manufacturing Records.
- File and maintain documents.
- Coordinate destruction of expired records and documents.
- Perform other related duties as assigned by QA Supervisor.
- Minimum of one year relevant work experience in document control management and/or equivalent combination of education and experience
- Technical writing experience preferred
- Good verbal and written communication
- Ability to follow instructions
- Ability to work independently and in a team environment
- Ability to edit and proof documents
- Good attendance and punctuality
- Excellent organizational skills/ attention to detail/ ability to work under pressure
- Ability to prioritize work and multi-task
- Strong interpersonal skills
- Minimum High School Diploma, AA or higher degree preferred
- Working knowledge of cGMPs and FDA regulations as it pertain s to document control
- General proficiency in using Microsoft Word, Excel, Outlook and Power Point Work
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles and risk of electrical shock.
- The noise level in the work environment is usually moderate.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision and Ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.