RESPONSIBILITIES & ACCOUNTABILITIES
- Responsible for DC, management of Document Control Request process, and maintenance of quality records (electronic and hardcopy files).
- Responsible for set up, configuration, validation and implementation of electronic document management system.
- Responsible for training department power users to use newly implemented electronic document management system.
- Operates data capture technology to upload/import electronic documents into document management system.
- Responsible for management activities related to personnel qualification and training, as well as ensures maintenance of automated and manual training documentation and personnel files.
- Performs periodic reviews of controlled documentation and assessments of internal files.
- Performs and participates in QA activities that include, but not limited to the following:
- Audit activities, including planning, scheduling, monitoring and documentation
- TMS software qualification and monitoring all the computer system validation activities
- Batch records issuance
- Change controls issuance and monitoring
- Equipment database verification and hard copies filing
- Log book issuance for production and QC equipment
- Involved in the development, review and revision of procedures in accordance with the QMS.
- Performs other departmental activities as needed and upon request
EDUCATION & EXPERIENCE
- Requires Associate degree and 3 to 5 years of experience in DC/ QA activities, or an acceptable combination of education and experience.
- Previous experience setting up, qualifying and training working personnel to use electronic document management systems (similar to Trackwise, LIMS, Livelink, Master Control) is essential.
- Experience in medical device, pharmaceutical and/or clinical research industry preferred.
- Working knowledge of regulations, standards and guidelines related to quality in cGMP environment.
- Excellent written and oral communication, attention to detail, organizational and planning skills.
- Proficiency with Microsoft Word
- Ability to perform and maintain quality work while prioritizing and managing multiple deadlines.
- Ability to work with different departmental designees on documentation-related activities.
This is a full-time position requiring 40 hours of work per week Monday through Friday