What are the responsibilities and job description for the Document Control Specialist position at The Wright Group?
Job Description:
The Document Control Specialist administers the approval, storage, and distribution of controlled documents (procedures, specifications, certificates, registrations, records, reports, etc.) using site document control systems. The Specialist checks documents and reconciles errors or discrepancies. Disseminates knowledge to staff on document control processes and procedures. The Specialist ensures that approved documents are accessible, and that the quality system repository is updated and maintained.
Job Responsibilities:
The Document Control Specialist is responsible for day-to-day administration and oversight of the company’s document control system. Responsibilities include processing document change requests, standard operation procedures (SOP), regulatory documents, forms, and key business process documents. The Document Control Specialist also maintains documents related to, but not limited to: training verifications, corrective and preventative action (CAPA), non-conformances, quality investigations, customer complaints, batch records, recall notices, supplier and internal audits, supplier documents and other internal and external correspondence.
Duties and Day-to-Day Responsibilities, but not limited to the following:
• Overall control and maintenance of all documents and records.
• Prepare, distribute, and control documents in accordance with the document control procedures. Confers with document originators or other personnel to resolve discrepancies and compiles required changes to documents.
• Ensures SOPs are written in the required format and that document control and change request processes are followed. Expedite review, signature approval, and release of documents, as necessary.
• Generate and have knowledge in compiling necessary information for the following types of documents: MSDS, Allergen Statements, GMO Statements, Kosher/Halal Certificates, Origin Statements, Certificates of Origin, Nutritional Statements, Animal Origin Statements, Internal and External Specifications.
• Establish and maintain files and computerized files for active documents. Generate electronic/hardcopy reports as needed. Process permanent, long term, short term, and vital records in all media forms.
• Assist in preparing draft manuals, drawings, and specifications.
• Responsible for distribution of finalized SOPs to the appropriate department(s). Establish and maintain a record of controlled documents on distribution.
• Assists in the coordination across departments and business units to revise an existing SOP or to create a new SOP.
• Monitors SOPs and other documents requiring revision and sends out notifications to other departments for the SOPs and documents requiring annual review.
• Assigns appropriate SOP number, work instruction number, Document Change Request (DCR) number, CAPA number, investigation number or other numbers for forms or documents as necessary.
• Retrieves copies of all required documents shared on electronic hard drive and in hard copy format to satisfy regulatory requirements.
• Maintains and archives completed paper and electronic versions of documents. Arranges disposal of documents.
• Other duties as assigned.
Minimum Training, Education, and Experience Requirements:
Bachelor’s degree and one year of related work experience in office work and documentation control; and/or an equivalent combination of work and education experience.
• Knowledge in use of spreadsheets, database, word processing, and electronic inventory systems.
• Experience working with large volumes of documents.
• Proficient in Microsoft Office suite of applications including Word, Excel, PowerPoint, Outlook, and Visio.
Key Metrics:
The Document Control Specialist will be held accountable for the following metrics (not all inclusive) as it relates to the operational area assigned. Additional metrics may be assigned.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job:
• Office and manufacturing environment.
• Sedentary physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.
• Visual requirements are for close vision, distance vision, peripheral vision and ability to adjust focus. 50% or more time is spent looking directly at a computer.
• Specialist is occasionally required to stand, walk (or otherwise be mobile).
• Ability to deal with stressful situations as they arise.
• Ability to perform in a fast-paced operation that can run 24/7
overtime and weekends may be required at times
