About the Role
The QA Document Control specialist will focus on maintaining overall document control structure within Happify’s quality management system. Responsible for the implementation, management and maintenance of the document management system in accordance with the Quality System and relevant regulatory requirements. Perform quality assurance duties under limited supervision. Works in accordance with Company Standard Operating Procedures (SOP). #LI-REMOTE
Responsibilities
- Provide general support for the overall Quality Management System.
- Create and modify user accounts and administer training programs in eQMS according to established procedures.
- Provide end user training on eQMS and other systems within the scope of job responsibilities.
- Coordinate document reviews and approvals to meet project timelines.
- Ensure documents meet formatting and template requirements.
- Compile metrics for document control to identify areas for quality system improvements.
- Perform administrative tasks to maintain the document management system.
- Coordinate Change activities/Change Orders such as the revision of product specifications, documents, etc.
- Provide documentation support during client audits and regulatory inspections.
- Author or revise SOPs related to document control, as needed.
- Generate and distribute meeting minutes for routine quality system meetings.
- Assists with the improvement of quality compliance by identifying recurring issues and trends.
- Manage incoming requests to the QA department by resolving independently or elevating to senior QA personnel.
- Finalize and publish working documents like SOPs, forms/templates etc.
- Support internal and external audits and inspections.
Qualifications
- A bachelor’s degree and a minimum of 3 years of relevant Document Control experience in a regulated industry.
- FDA and ISO 13485 experience required.
- Ability to take direction, work independently, manage time, and effectively interact with various groups and personnel.
- Experience with eQMS system and GMP documentation.
- Strong skills with common computer software such as Microsoft Office (Word, Excel, PowerPoint).
Happify values candidates with different backgrounds, experiences, and perspectives. We do not discriminate based upon ethnicity, age, gender identity and expression, sexual orientation, religion, national origin, socioeconomic status, disability, or veteran status. We’re committed to building a company that is an inclusive environment for all.
There have been cases of scams targeting candidates by individuals pretending to work at Happify. We will never ask you to share financial information to participate in our recruiting process. If you suspect that you’ve been contacted by a scammer, please consider filing a report with law enforcement. If you’d like to verify an email you received from Happify, please write us at [email protected].