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Document Control Specialist
Position Reports To: Document Control Supervisor
Position Directly supervises: No one
Job division: Business Operations
Over-Time Status: Non-Exempt
Purpose Of Position: Responsible for the maintenance of all active and inactive documents pertaining to the production and testing of all Agena products. Ensures the timely and accurate processing of Change Orders (COs) and new documentation. Processes the review and revision of procedures, specifications, forms, and other controlled documents. Supports Quality Assurance department by maintaining electronic files to support Agena’s quality documentation .
To fulfill this position successfully, an individual must be able to perform each essential function satisfactorily.
- Maintains all Engineering and Product Development records to ensure integrity and accessibility including but not limited to photocopying and scanning documents.
- Processes and controls storage of Quality Records.
- Interacts directly with users of controlled documentation to ensure internal conformance to company quality control requirements.
- Processes review and approval workflows in electronic document management system.
- Reviews document format to ensure compliance to Good Documentation Practices (GDPs).
- Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding marketed products, as requested.
- Tracks and facilitates timely documentation review and implementation.
- Distributes documents in accordance to control procedures.
- Ensures accurate and timely input of database entries; implements a self-auditing system to verify work.
- Analyzes change requests for completeness.
- Provides support to internal customers with documentation needs.
- Updates electronic document profiles to reflect appropriate changes.
- Provides clerical and administrative support related to documentation processes and systems.
- Creates and maintains document templates by coding fields and uploading into the electronic document management system.
- Routes and releases documentation.
- Follows up on training requirements to ensure compliance to the department’s standard operating procedures.
- Assists with monitoring the Document Control email inbox to ensure all requests are assigned and responded to in a timely manner. Communicates among the Document Control team to ensure request are fully completed.
- Maintains the document archival room; ensures files are accurate and easily retrievable.
- Assists with training program by filing training records and logging training.
- Works with a variety of internal teams to ensure receipt of training materials.
- Performs other related duties and projects as business needs require at direction of management.
The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add, subtract, or change the job functions.
Minimum Qualifications: The requirements listed below are representative of the knowledge, skill, and ability necessary to successfully perform the essential functions of the position.
- Education and Experience:
- High school diploma or equivalent.
- Minimum two (2) years of experience in dental or medical device industry.
- Minimum one (1) year of customer service experience.
- Demonstrated knowledge of document control fundamentals, quality systems, and Good Manufacturing Practice (GMP) requirements.
- Demonstrated understanding of current medical device industry and applicable regulations.
- Ability to keyboard forty (40) to forty-five (45) words per minute (WPM) accurately.
- Ability to exhibit awareness and sensitivity to the needs of internal and external clients to proactively ensures these needs are met or exceeded.
- Must possess proficient English skills, both written and verbal.
- Must possess effective oral communication and interpersonal skills with ability to deal with all levels of personnel in a professional and effective manner.
- Proven ability to develop strong relationships across multiple functions.
- Ability to communicate clearly with employees, management, and team members.
- Ability to convey information in a clear and concise manner.
- Ability to communicate effectively in a multi-cultural business environment.
Knowledge and Abilities:
- Proficient knowledge of general office procedures.
- Proficient skills in the MS Office Suite (Word, PowerPoint, and Outlook); advanced proficiency in Excel.
- Demonstrated prioritization and time management skills.
- Demonstrated high standard of quality of work.
- Demonstrated reliability, dependability, and flexibility in work habits.
- Demonstrated attention to detail and accuracy.
- Ability to prioritize and organize project tasks and goals effectively.
- Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
Physical Demands: The physical demands listed below are representative of those that must be met by an employee to successfully perform the essential functions of this position.
§ Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.
§ Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.
§ Ability to frequently communicate with others.
§ Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.
§ Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.
§ Ability to frequently stand and/or walk for extended periods of time.
§ Ability to seldom climb stairs at some locations.
§ Ability to frequently push and/or pull up to fifteen (15) pounds.
§ Ability to frequently lift or carry up to fifteen (15) pounds.
§ Ability to keyboard for extended periods of time.
§ Ability to function in an environment with frequent interruptions.
§ Ability to deliver quality results under high pressure deadlines in a fast-paced environment.
§ Ability to demonstrate normal manual dexterity and eye-hand coordination; maintain corrected hearing and vision to normal range.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position.
- Primarily an office-setting environment with moderate noise levels and no direct exposure to hazardous physical substances.
[EM1]What is Agena Products, is this another company??
[EM2]This needs to be removed. Change / remove company name