Document Control Specialist
Document Control Specialist
This opportunity is ideal for a rising professional to develop their career and gain experience from C-Level executives. This position entails developing and maintaining record retention and archive processes. Bringing record and document control area into compliance. Identifying and improving opportunities. Support quality, product development, and manufacturing department record control function. Be able to quickly learn companies EDM system.
Duties and Responsibilities
- Organize and maintain hard copy, electronic, and EDMs controlled records and documents including DHF, 510K, LHRs, etc.
- Maintenance of historical records (manual and electronic): archiving of hard copy records, managing of outside archival resources, and manage Document Control Room
- Provide expert service in maintaining chain of custody on requested records
- Perform document control QC check of QMS documents
- Maintain backups of logs and records
- Manage change control activities
- Supervise temporary employees for special, short-term document control projects
- Aid with document research projects
- Assist with assembling documentation packages for regulatory agencies with senior regulatory team
- Provide Audit support with Sr. Team members
- Administrative assistance to VP QA/RA
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software.
- High School Diploma
- 3-4 year of experience in Document Control, preferably in an ISO 13485 or FDA regulated environment.
- Knowledge of ISO 13485, FDA and MDD concepts and guidelines preferred.
- Must be able to work within an EDM system
- Understand and implement GDPs
- Excellent communication and organizational skills.
- Strong attention to detail.
- Strong interpersonal skills and ability to work with others in a positive and collaborative manner in office environment.
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
- Knowledge of various MS Office applications such as: Word, Excel, Powerpoint and Visio.
- Ability to handle multiple tasks in a fast-paced environment and still provide accurate and complete work.
Applying for the job
There are various ways to apply for this position:
- Apply direct from the website (www.tecgroup.net) by clicking "apply now"
- Contact the consultant directly:
About TEC Group International
We are TEC Group. We are international recruitment specialists. We are the link between highly-specialised industries and the professionals that make them work. Expert consultants, a global network of offices and the latest technology allow us to join the dots in the talent process.
TEC Group International supports the Scientific, Engineering and Energy sectors. We have completed assignments in over 60 countries and support projects all over the world through our subsidiaries and partners.