The Documentation Specialist is a clerical specialist who coordinates various aspects of electronic document control. The Documentation Specialist is responsible for administering the processes and practices which support documentation compliance. The Specialist will work in pharmaceutical production and in close collaboration with production with a key-focus on documentation accuracy, quality, and integrity.
Perform daily entries and updating production updates and other tasks necessary to ensure the accuracy and timeliness of data.
• This position has no direct reports
• Maintain the flow of hard copied controlled documents, department files and resource material
• Authoring and maintaining batch records, writing SOP’s, writing protocols and preparing reports for manufacturing, packaging, supply chain and facilities/engineering.
• Helping department head in tracking production outputs and developing monthly, quarterly and yearly production reports
• Helping department head with raw material and packaging material ordering
• Review production control documents
• Performing SAP transactions as requested by packaging/production departments
• Tracking and maintaining personnel training records
• Coordinate EHS activities and maintaining OSHA related records
• Performing periodic safety audits and advising company on safety related issues
• All the other job duties related
Specialized Skills and Knowledge:
• High school Diploma or equivalent
• Basis Math Skills
• Operate with strict adherence to SOPs and cGMPs.
• Departmental safety rules.
• Knowledge on EHS/OSHA regulations
• Good dexterity and eye hand coordination.
• Strong Written, Oral and communication skills in English.
These are the skills, traits, qualities or characteristics that contribute to a person’s ability to perform responsibilities in an organization. Examples include but are not limited to: decision making, collaboration, leadership, communication, problem solving, adaptability and initiative. You must list the three most critical competencies.
3. Adaptability and Initiative
This position is sedentary in nature. The employee may occasionally lift and or move up to 25 pounds.
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.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.