Document Control Admin Assistant

Nesco Resource is looking for a Document Control Administrative Assistant located in oxford, CT

This is a temp to perm opportunity for the right candidate.

Shift: Monday-Friday 8AM-4:30PM (30-minute unpaid lunch)

Pay: $17.50/Hour

Position Overview: Responsible for the collection, maintenance and distribution of all documents necessary to define product configuration and control manufacturing processes that insure conformance to customer requirements

Maintains a comprehensive filing system and computer database for all documents to be retained in the latest revision of appropriate documentation in a timely manner

Document Control Administrative Assistant is also responsible for the Training Program Management

Duties & Responsibilities:

• Collect and maintain files of the latest revision level documentation necessary to define product configuration and control manufacturing processes in the QT9 System
• Process & Implement changes to controlled or new documents using the QT9 QMS System
• Maintain a computer database of all filed documentation that ensures fast retrieval of documents.
• Review, print and timely distributes the latest revision level documentation to all appropriate users and ensure removal of obsolete documentation from distribution
• Responsible for digital submission of drawings via various customer/supplier's web interfaces
• Correspondence/handling customer/supplier issues including distribution and re-submittal of revisions
• Maintain the Approve Vendor List, Monitor Certificates and Evaluation due dates and follow up completion of actions needed to maintain accuracy in QT9.
• Monitor until closure Customer Complaints, CIR, CAPAs, Deviations, Product reworks, NCRs, Quality Plans, RPCs, EOVRs & TIR logs VS files, ensure content is correct and complete and keep logs up-to date
  Scan all documents.
• Ensure the training program performance is measured, and proper communication is done to each team to ensure meeting objectives for training closure.
• Create training records as needed and monitor them until closure.
• Serve as one of the global administrators of the QT9 QMS System.
• Manage and review accuracy of documentation using QT9 prior to release.
• Monitor and document GDP errors in device history files
• Seek out and complete methods to continually improve processes
• Perform related duties as assigned by supervision
• Arrive at meetings on time and prepared to participate
• Maintain a cooperative working relationship with, supervisors, and all other staff members
• Maintain a positive attitude and be a positive example to coworkers
• Perform all duties in a manner that is compliant with all applicable regulatory bodies (FDA/ISO)
• Communicate effectively with co-workers
• Respect the confidentiality of the company, our customers and each other
• Perform other duties and tasks as may be assigned by the Supervisor

Skills & Attributes:

• High School Diploma, or equivalent
• 2 years of related experience in fast-paced office environment, Medical Manufacturing a plus
• Experience in digital records management in a medical device manufacturing environment (Not required, but preferred)
• Ability to accept direction and feedback from Supervisors, Management Team, and Leadership Team and follow through appropriately
• Ability to adjust to major changes in work tasks or environment
• Maintain a customer-focused perspective in all activities initiated to ensure that customer needs are successfully met
• Develop professional and process expertise to provide improved assistance to internal and external customers
• Basic reading and comprehension skills
• Have good communication skills, both written and verbal in English
• Have good technical publishing and organizational skills
• Have keen attention to detail
• Familiar with general office practices and procedures
• Able to work with the following programs on an intermediate level: Adobe Acrobat, Microsoft word, Excel, Access and Outlook; as well as Internet Explorer and Windows
  
• Able to carry out detailed written or oral instructions
• Able to understand proper handling of all paperwork required in department.
• Able to manage several projects at one time with frequent interruptions
• Knowledge of engineering drawings & documentation (not required but preferred)
• Able to work in a fast-paced environment under minimal supervision.
• Willingness to learn and adapt to new processes and procedures
• The QA/RA Manager is kept informed of daily activity
• Attendance and Participation at Company Meetings
• Communicate to the QA/RA Manager status of systems like Customer Complaints, CIR, CAPAs, Deviations, Product reworks, NCRs, Quality Plans, RPCs, EOVRs & TIR logs
• On time delivery/implementation of agreed commitments / Special Projects
• Approved vendor list kept current
• Other tasks assigned by the Supervisor are performed in an accurate, complete, and timely manner
• Adhering to attendance policy

Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.