Summary
The Production Document Control Specialist will be responsible for maintaining an organized and detailed library of project documentation primarily using SharePoint. The Document Controls Specialist will be responsible for the administration and control of documents that are received, created, or issued as part of the Production team. Works closely with the QA project team.Key Responsibilities
- Maintains, organizes, and updates documents in electronic drawing management systems. Familiarity with SharePoint preferred
- Complete administrative and analytical support with the Production and QA document control services
- Demonstrates adherence to QA document services policies, procedures, standards, and guidelines
- Provides services for quality assurance document requests
- Communicates document requirements and client standards
- Performs collection, entry, and distribution procedures as required
- Ensures document transmittals by others are accurate and complete
- Utilizes interpersonal skills in maintaining balance with all parties’ requirements and priorities
- Proactively communicates with the production and QA staff and internal teams to manage workload and project requests
- Contributes to the development of department policies, including documentation, storage, and organization policies
- Initiates corrective action for continuous improvement of efficiency and customer service
- Performs quality assurance and quality control of quality assurance documents
- Performs periodic archiving and audits to maintain document repository standards
- Investigates compliance as necessary
- Support of quality documents with verification of document accuracy through audits
- Works with manufacturing leads to maintain inventory of consumable items
- Works with the Procurement department to issue purchase requests through SAP for consumables and other approved items
- Contributes to team effort by accomplishing related results as needed
- Other duties as assigned
Education and Experience
- High School Diploma or equivalent required
- Associate degree or higher preferred
- 2 years of previous document control experience in a quality assurance environment, or alike environment
- Microsoft Office Applications Experience (i.e. Excel, Word, etc.)
- Strong communication and organization skills, both verbal and written
Knowledge, Skills, and Abilities
- Demonstrated proficiency in analyzing data, problem identification and resolution, and the ability to generate clear/concise reports indicating key issues
- High attention to detail
- Ability to interpret a variety of instructions furnished in written and oral form
- Ability to work on multiple tasks and prioritize work
- Must be willing to work extended hours as necessary
- Ability to work cross-functionally as a team
- Strong PC and Microsoft Office skills
- Possess the skills and ability to coordinate, facilitate, and participate in a collaborative approach for the completion of tasks and assignments
- Actively participates as a member of the Production and QA team to move forward with the completion of projects and goals
- General understanding of basic quality assurance principles, FDA requirements
- Excellent understanding of department operating practices and procedures
- Excellent interpersonal, verbal, and written communication skills
- Flexibility to handle multiple tasks simultaneously in a competent and professional manner
Physical/ Work Environment/ Expectations:
- GMP Manufacturing Environment
- The work environment, typical of an office environment, characteristics described here are representative of those encountered while performing the essential functions of this job.
Note: This job description is not totally inclusive nor it is designed to cover or contain a complete comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
