Senior Document Control Specialist (QA) - Onsite SD

Generis TEK Inc.; San Diego (CA); Presencial; USD 36.000 - 52.000; Jornada completa

Descripción de la vacante

Generis TEK Inc. in San Diego, CA is recruiting a Senior Document Control Specialist (QA Specialist) for a 3-month contract onsite. The role focuses on maintaining the Document Control Management System, supporting quality metrics and QA activities to uphold the QMS.

The successful candidate will manage change orders, ensure documents meet regulatory requirements, and coordinate cross-functional reviews. Strong writing, formatting, and documentation skills are essential.

Formación

• Bachelor’s Degree or an equivalent combination of education and experience.
• 2+ years of experience in Quality Assurance or Document Control in a regulated lab/medical device setting.
• Working knowledge of 21 CFR 820 and ISO 13485:2016.
• Experience with electronic document management systems.
• Experience with technical writing, formatting, and data trending.
• Experience with Agile Document Management System.

Responsabilidades

• Act as Change Order Coordinator for the facility.
• Coordinate document change orders and deviations; manage reviews and approvals.
• Ensure new or revised documents meet regulatory requirements and are approved by relevant functions.
• Issue document, lab notebook, and part numbers.
• Assist in drafting and editing SOPs for the Quality Management System.
• Manage archiving, obsolescence and storage of controlled documents.
• Provide Document Control training and contribute to QA training materials.
• Support QA metrics trending and management review.
• Assist with internal and external audits.
• Support continuous improvement of the QMS, focusing on document control and change order processes.

Conocimientos

Document control

Quality assurance

Metrics trending

Educación

Bachelor’s degree or equivalent

Herramientas

MS Office

Descripción del empleo

Generis TEK Inc. in San Diego, CA is recruiting a Senior Document Control Specialist (QA Specialist) for a 3-month contract onsite. The role focuses on maintaining the Document Control Management System, supporting quality metrics and QA activities to uphold the QMS.

The successful candidate will manage change orders, ensure documents meet regulatory requirements, and coordinate cross-functional reviews. Strong writing, formatting, and documentation skills are essential.