Document Control Specialist II
Responsibility:
- The Document Control Analyst facilitates the Change Control process for in the electronic change control system as well as tracks the change process through development, approval, and implementation.
- Analyzes and interprets the significance of the proposed changes using independent judgment to guide change initiators in the development of accurate change requests.
- Reviews standard operating procedures, logs, forms, manufacturing records, work instructions and all other Quality records for adherence to established templates, good documentation practices and adequacy of referenced procedures and part numbers.
- Communicates issues effectively and partners with cross-functional associates to meet compliance requirements.
- Receives, classifies, files, audits, tracks and maintains centralized documentation archiving system.
- Collects and enters data for the creation of metrics and reports for various departmental activities.
- Exercises good judgment and uses decision making skills to effectively perform job responsibilities.
- Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Perform other duties & projects as assigned.
Requirement:
- High School Diploma
- Intermediate knowledge of Microsoft Word, Excel and Microsoft Access.
- 2-4 years of experience preferably in an FDA regulated facility.
- Must be able to work under minimum supervision
- Must possess excellent communication skills, both verbal and written
- Ability to handle multiple projects simultaneously and to prioritize tasks
- Works well with others in a team environment
- Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
- Demonstrate problem-solving and troubleshooting skills
- Organized and detail oriented